Belgian data is current through November 2018. All of the data comes from the Federal Agency for Medicines and Health Products, except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of data from the U.S. and Belgium.
Belgian data is current through November 2018. All of the data comes from the Federal Agency for Medicines and Health Products, except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of data from the U.S. and Belgium.
Belgian data is current through November 2018. All of the data comes from the Federal Agency for Medicines and Health Products, except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of data from the U.S. and Belgium.
Belgian data is current through November 2018. All of the data comes from the Federal Agency for Medicines and Health Products, except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of data from the U.S. and Belgium.
Brazilian data is current through June 2018. All of the data comes from Anvisa, except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of data from the U.S. and Brazil.
Notes supplémentaires dans les données
Medtronic does not recommend the prophylactic replacement of SynchroMed II pumps with the previous battery design because of the estimated low occurrence rate, the presence of pump alarms, and the risk associated with replacement surgery. This opinion has been reviewed and is supported by the panel of specialized external physicians. However, proper consideration should be given to the medical needs of each patient. When critical and non-critical alarms listed below occur, Medtronic strongly recommends that replacement surgery be scheduled as quickly as possible for these patients.
Cause
This notice provides an update to information previously reported to physicians in july 2011 regarding the reduced battery performance failure rate on the medtronic model 8637 synchromed® ii pump manufactured as of june 2011 (medtronic's reference: fa522). this notification reinforces previously reported patient treatment recommendations regarding this problem. this notification does not apply to currently distributed or deployed synchromed ii devices or to any device manufactured after june 2011. in latin america, medtronic began distributing the synchromed ii pumps with a new battery design in july 2011.
Action
Field Action Code FA760 released under the responsibility of the company MEDTRONIC COMERCIAL LTDA. Company will update, correct or supplement the instructions for use.
Brazilian data is current through June 2018. All of the data comes from Anvisa, except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of data from the U.S. and Brazil.
Notes supplémentaires dans les données
The batches of the Paradigm Medication Reservoir product reported on this alert were marketed from October 2012 to May 2013. Any questions, please contact Medtronic at 08007739200. #### UPDATE: The field action was finalized by the company on 11/18/2013.
Cause
Medtronic is developing two concurrent field actions related to medtronic's paradigm infusion system, one for safety and another for recall. a) the first relates to a safety problem that may occur if insulin or other fluids come into contact with the medtronic paradigm infusion set connector. exposure from the inside of the infusion set connector to the insulin may occur if the insulin is spilled on top of the insulin reservoir when the reservoir is removed from the blue transfer shield after filling the reservoir from an insulin bottle. if this occurs, insulin may temporarily block the openings in the connector that allow the pump to function properly. if the openings are blocked, this can probably result in the delivery of more or less insulin, which can lead to hypoglycemia or hyperglycemia, which in extreme cases can lead to loss of consciousness or death. b) the second field action refers to the collection of some batches of reservoirs, model mmt-326a and mmt-332, used with the paradigm insulin infusion pumps, due to the risk of leakage. a leak in the reservoir may result in the delivery of less insulin than is programmed, and if there is an occlusion in the infusion set, the pump may not report through the alarm.
Action
A) the company advises that, in order to prevent insulin from blocking the connector openings, the user should: 1. After filling the reservoir, ensure that the insulin bottle is kept upright when removing the insulin shield reservoir. blue transfer. This prevents insulin from inadvertently leading to the top of the reservoir, which could transfer the insulin into the infusion set connector. Hold the insulin bottle upright when removing the reservoir. 2. If any liquid (such as insulin, isopropyl alcohol, or water) reaches the top of the reservoir or the inside of the infusion set connector, start again with a new reservoir and infusion set. B) As for the reservoir, it is important that the user verify that the batch numbers of all MMT-326A and MMT-332A reservoirs in their possession are listed in the letter attached to this alert. You can also check the batch number of your reservoirs at the following site http://www.medtronic-diabetes.info to confirm whether your reservoirs are included or not in this action. If all reservoirs held by the user are involved in the recall, the company recommends that the use be immediately stopped and the user to use syringe or pen for the administration of insulin, as prescribed by their physician until that receives new reservoirs. The company directs that any reservoir that has not been used and included in this recall should be discarded, but that the bar code label of the container box or the individual containers of the containers should be maintained since these will be required to submit an order of reservoir replacement. Reservoirs whose batches are not listed in this alert can be used. The company informs that it will replace all the reservoirs of the affected lots at no cost. For more information, please refer to the letters attached to this alert, as well as the company's website: http://www.medtronic-diabetes.info.
Brazilian data is current through June 2018. All of the data comes from Anvisa, except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of data from the U.S. and Brazil.
ICU Medical, Inc. acquired from Pfizer in early 2017, Hospira Infusion Systems, the portion of Hospira dedicated to develop infusion pumps.
Notes supplémentaires dans les données
Calibration of the proximal and distal pressure sensor may vary, resulting in failure of the pump's Proximal or Distal Occlusal Operation Test as described in the GemStar Service Technical Manual, or exhibiting one of the following errors during infusion or pump configuration : Check Cassete - D; Check Cassete - P; Proximal occlusion; Distal occlusion; Pressure Calibration Error; Damaged Pressure Sensor Event; Damaged Pressure Sensor Status; Distal Pressure Out of Limit; Proximal Sensor Off limit. A pump with this problem may, instead of reporting an error, not detect occlusions or emit false occlusion alarms, which will interrupt the infusion and cause the device to emit visual and audible alerts. If these failures are observed the infusion is interrupted, resulting in delayed / interrupted therapy. An undetected distal occlusion can cause excessive pressure and accumulation of fluid in the distal line not detected by the pressure sensor. When distal occlusion is resolved, fluid accumulation will be administered to the patient and may cause a maximum overdose of <1.0 mL. The severity of the delay or discontinuation of therapy depends on the underlying condition of the patient and the prescribed treatment. A delay / interruption in therapy may, in the worst case, result in a serious adverse event. Health professionals are advised to evaluate the risks / benefits to patients associated with the use of the equipment when administering critical therapies. Clients should contact a Hospira representative for the use of an alternative pump, particularly for patients in whom delayed / discontinued therapy or overdose can lead to serious injury or serious adverse events. It is recommended to perform proximal and distal occlusion tests as described in the Gemstar Technical Service Manual. If the pump fails one of the tests, it must be withdrawn from use. If you are unsure whether to perform the tests or if the infusion pump fails during one of the tests, contact Hospira on 0800-7733133 to report the problem and send the pump for recalibration. Performing distal and proximal occlusion tests should be included in the annual preventive maintenance schedule. Access the letter to the clients, see the link: http://portal.anvisa.gov.br/wps/wcm/connect/a59744804f8690b9b60cf79a71dcc661/FA302-02_Messagem+de+Alerta.pdf?MOD=AJPERES #### UPDATED IN 23 / 08/2017, the field action documentations sent by the company are filed in the area. If necessary, the area can reassess the action at any time.
Cause
Calibration of the proximal and distal pressure sensor may vary, resulting in failure of the proximal or distal occlusal operation test of the pump.
Action
Sending the letters to the clients (hospitals and distributors) and updating the Technical Service Manual indicating the performance of the distal and proximal occlusion tests in annual preventive maintenance.
Brazilian data is current through June 2018. All of the data comes from Anvisa, except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of data from the U.S. and Brazil.
ICU Medical, Inc. acquired from Pfizer in early 2017, Hospira Infusion Systems, the portion of Hospira dedicated to develop infusion pumps.
Notes supplémentaires dans les données
Company Field Action Code: FA302-01. The severity of the delay or discontinuation of therapy depends on the underlying condition of the patient and the prescribed treatment. A delay / interruption in therapy may, in the worst case, result in a serious adverse event. Lithium batteries older than 3 years must be replaced. Health professionals are advised to evaluate the risks / benefits to patients associated with the use of the equipment when administering critical therapies. Clients should contact a Hospira representative for the use of an alternate pump, particularly for patients in whom delayed / discontinued therapy can lead to serious injury or serious adverse events. For customers who periodically check the historical records of Gemstar infusion pumps, it is suggested that it be performed more frequently to reduce the amount of information in the registry that could be lost if this failure occurs. Instructions for downloading the files can be found in the Gemstar System Operation Manual. Access the letter to the clients, see the link: http://portal.anvisa.gov.br/wps/wcm/connect/a916b8804f868f5fb603f79a71dcc661/FA302-01_Message+of+Alerta.pdf?MOD=AJPERES #### UPDATED IN 23 / 08/2017, the field action documentations sent by the company are filed in the area. If necessary, the area can reassess the action at any time.
Cause
An internal, non-user lithium battery is used to power the memory that stores current infusion settings and event history records when the pump is turned off. if the battery voltage level falls below 2.4 volts, an 11/004 error will be displayed and the infusion pump can not be used, resulting in possible delay / interruption in therapy. in addition, the infusion settings and event history records will be cleared.
Action
Replacement of lithium batteries older than 3 years.
Brazilian data is current through June 2018. All of the data comes from Anvisa, except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of data from the U.S. and Brazil.
Notes supplémentaires dans les données
According to Medtronic Ltd., based on data from the Medtronic Implantable Systems Performance Registry (ISPR), the overall failure rate of the SynchroMed II pump, at 78 months after implantation, is 2.4% when it is used to infuse approved drugs, and 7.0% when used to infuse non-approved drugs. The use of unapproved drugs can lead to intermittent or permanent pump motor blockages, which can be reported as a loss of or change in therapy - pumps may present motor blockages when used with approved or unapproved drugs, however, of the pump motor were reported at a significantly lower rate when only approved drugs are used (as quoted above). Additional information: Alert message published by the company at: http://portal.anvisa.gov.br/wps/wcm/connect/1a4a23004d9b08eab88ef9c116238c3b/Carta_de_Comunicacao_ao_Cliente.pdf?MOD=AJPERES. List of drugs approved for use in Synchromed pumps: http://portal.anvisa.gov.br/wps/wcm/connect/4c479d804d9b095bb897f9c116238c3b/Lista_dos_Farmacos_Aprovados.pdf?MOD=AJPERES Report on increased risk of engine crash: http: / / / / / / / #### UPDATE (03/13/2013): This field action was finalized by Medtronic Comercial Ltda on 02/02/2013 (see file 0126047 / 13-2). The company showed the sending of warning messages to customers who own the product at risk. ####
Cause
Use of non-approved drugs for synchromed infusion pumps may increase the chance of intermittent or permanent motor blockage, leading to underdosing or loss of therapy.
Action
The company is sending an alert message ("Urgent Safety Warning - Use of Unapproved Drugs with the Synchromed Implantable Infusion Pump), with information about the problem and ways to avoid it - not using drugs that have not been approved for the product concerned.
Brazilian data is current through June 2018. All of the data comes from Anvisa, except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of data from the U.S. and Brazil.
Notes supplémentaires dans les données
The company informs you that your customers can perform a history event review of their pumps and any pump that has a history of error codes mentioned above must be removed from service. If you have questions about how to access the event history, check the attached Equipment Manual page or contact the Baxter Hospitalar Technical Service at 0800125522 option 3. All Colleague Infusion Pumps that are in the process of being evaluated by the Technical Service (Baxter) will have the verified event history, before returning to customers, for any fault codes listed above. If pumps are found that have any of these fault codes, this pump will not return to customers until corrective action is implemented. Baxter Hospitalar Ltda will retain shipments of new Colleague Infusion Pumps until this problem is resolved. If you have any questions about this, please contact your Baxter Hospitalar Ltda representative or call the service center at 0800 12 55 22 option 3 or email vivian_escobar@baxter.com or carmine_maglio@baxter.com. ANVISA will be accompanying the actions that will be carried out through the company with regard to the entire process of correction and replacement of said product. - /// --- Brasília September 5, 2005 - 5:37 pm - / - Regarding the corrective field action that Baxter has been carrying out, the company informs:. Pumps active in Brazil: 4,761. Pumps already rated: 2.586. Pumps with indication of defects: 53 - (2.05%). Remainder: 2.175 Further informed that it sent communication to 136 clients, returned from 43 receipt indications, with a forecast for the end of the evaluations for September 30, 2005. - /// --- Brasilia September 12, 2005 - Letter Considering that the pumps, when presenting certain fault codes, immediately trigger the visual and audible alarms, alerting Nursing, and considering the initial tests showing a relatively low incidence of pumps that have been affected so far, we are reading the memory register (the pump stores the last 1000 events) to identify certain fault codes associated with that part. Once one of these codes has been identified, the pump is picked up (withdrawn and serviced). This action is being taken because the existence of any of these codes increases the possibility that it will occur again. To date, we have completed the verification in approximately 68% of installed pumps with an incidence of 1.7%. This incidence is in line with the average we have found in other countries. Our goal is to complete (100%) the checks in up to 3 weeks (late September). At the same time, a new electronic card and new software are being validated to replace the current ones. This action, board change and software, should be started as of December 2005.
Cause
Problem with colleague infusion pump design. this problem in the design involves a timing circuit that can interrupt the internal communication in some equipment.
Action
The company recommends that any pump that has the following error codes: 402,403, 532, 533, 534, 535, 599, 702, 703, 704, 720, 804:21, 804:22, 804:24, 804: 29, 804: 34, 804: 52, 804: 54, 804: 58 and 12: 303: xxx: 006, be withdrawn from service. Error codes 402, 403, 533, 535, and 599 were previously reported in Equipment Urgent Correction communication dated May 10, 2005. Colleague Infusion Pumps are designed to alarm, stop infusion, and display the error code on if an abnormal situation is detected. As this situation may occur during infusion, it is imperative that institutions have a contingency plan to mitigate any interruption during infusion therapy (eg, a reserve pump available). In addition, you should consider not using these pumps in a situation where pump replacement is not available or when a delay in therapy could be life threatening.
Brazilian data is current through June 2018. All of the data comes from Anvisa, except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of data from the U.S. and Brazil.
Notes supplémentaires dans les données
According to the Company, a corrective action was initiated in March 2011 through a Letter of Communication to Customers, informing about a potential failure in the equipment keyboard. Subsequently, on 06/06/2012, the Company verified that this action was not effective and, in addition, identified that the AUTOMIX system could suffer an intermittent electric fault, which may cause a sudden and unexpected stop of the product - this may lead to interruption of the mixing process performed by the product, without any alarm or "green" warning light visible, without the operator detecting the fault.
Cause
Possibility of intermittent electric failure.
Action
The record holder started collecting the product. If you have any product affected by this field action in your inventory, check Baxter's recommendations for product use in the Letter to Customer. To access the Letter to the Client, use the following link: http://portal.anvisa.gov.br/wps/wcm/connect/e6fdba004c34776ca906f9dc39d59d3e/Mensagem_de_Alerta.pdf?MOD=AJPERES
Brazilian data is current through June 2018. All of the data comes from Anvisa, except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of data from the U.S. and Brazil.
Notes supplémentaires dans les données
See attachments.
Cause
Paradigm quick set infusion catheter unexpected behavior at the time of the prime manual associated with the saturation of the p-cap opening membrane with silicone oil and therefore not allowing air to escape from the reservoir compartment can prevent ventilation of the pump of insulin, potentially resulting in excess or lack of insulin to be delivered, leading to serious injury or death.
Action
The actions recommended to the users of the product are as follows: (1) Immediate interruption of the use of infusion kits of this lot; (2) Switch to an infusion kit that has not been affected or implement the injection contingency plan established with your physician; (3) Contact your supplier to arrange for the return and replacement of any Quick Set "Batch 8" infusion kits at no additional charge.
Brazilian data is current through June 2018. All of the data comes from Anvisa, except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of data from the U.S. and Brazil.
Notes supplémentaires dans les données
Medtronic Inc. recently conducted a survey of the occurrence of chronic inflammation or granuloma in the distal portion of intrathecal catheters used in implantable infusion pumps (IsoMed, SynchroMed II and SynchroMed EL), particularly in cases of use of these same pumps in opioid infusion therapies, baclofen, drug-drug compounds and other pharmacological preparations. The exact cause of inflammatory mass formation is still unknown, but the higher rate of occurrence of this problem is associated with the use of opioids, particularly when using high doses, or high concentration doses, of morphine sulfate and / or other opioids. In December 2007, the company estimated the incidence rate of inflammatory mass (from reported cases) in patients implanted and submitted to infusion of drugs for pain treatment by 0.49%, higher than the incidence rate of 0, 1% reported in 2001. Medtronic Inc.'s expectation is that the rate of reported occurrences of this problem will increase as cases of this type have occurred between 6 months and> 10 years after implantation of the infusion device in patients. The symptoms reported in patients are as follows: decreased therapeutic response / inadequate attenuation of pain, pain, neurological dysfunction, paralysis / paraplegia, muscle weakness / weakness, numbness, incontinence, motor difficulties, urinary retention, tingling sensation, and headache . The risk of this problem occurring seems to be cumulative over time and increases as higher concentrations of opioids are used in the treatment.
Cause
Possibility of inflammatory mass formation at the tip of the intrathecal catheter used in isomed and synchromed ii implantable infusion pumps.
Action
The company that manufactures the product (Medtronic Inc. - USA) recommends that intrathecal opioids be administered in a way to provide an adequate analgesic action using the lowest doses possible. Physicians who accompany patients implanted with these infusion pumps should implant a routine of monitoring specific to the needs of each patient, aiming to identify the formation of inflammatory mass from clinical signs and symptoms presented. Special attention should be given to patients whose implant is used for infusion of drug-compound drugs, or preparations that include baclofen and opioids. The company currently in possession of the product registration in Brazil (DABASONS LTDA) informed the Anvisa's Technovigilance Unit that it has already initiated contact with its clients involved in this action, through letters of communication. According to the company, 484 units of these devices were marketed in Brazil to date, and there are also 28 non-marketed units retained in stock. The company said it had not marketed the Synchromed EL (also at risk) implantable infusion pump in Brazil. Anvisa's Technovigilance unit is following up on this case.
Brazilian data is current through June 2018. All of the data comes from Anvisa, except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of data from the U.S. and Brazil.
Notes supplémentaires dans les données
In Brazil - The company informs that no card was imported until the precious moment. Only 06 units of the N Vision Clinician Model 8840 programmer were imported in August 2004 but have not yet been used as there are no 8870 software application cards available. It further informs that this recall is limited to software application cards and does not include other equipment and accessories and no action to patients on this recall is required. Clarifies that it has developed a software replacement version AAA02 that provides additional information and clarifications of the time intervals designed to assist the user in the risk of error in data entry. These software application cards were distributed from December 2002 to May 2004. As of May 2004 Medtronic Neurological no longer distributed these cards. For more information, contact Medtronic by telephone at the above number or your local representative. ANVISA has provided the Occurrence Notification Forms on the Internet www.anvisa.gov.br/tecnovigilancia to notify you if you encounter any problems with the products in your inventory. For further information, please contact ANVISA's Tecnovigilância Unit, by e-mail tecnovigilancia@anvisa.gov.br or by telephone (61) 448-1485.
Cause
Medtronic has received overdose notifications associated with the use of the above-mentioned software cards when users mistakenly enter the periodic bolus interval value in the minutes field instead of entering them into the programmer's hours field. 4 patients with serious injuries and 2 deaths may have resulted from this problem. the manufacturer declares that this subject is limited to software cards when they are used to program synchromed and synchromed el pumps and does not include sybchromed ii pumps or any other equipment. the company has developed replacement software to reduce the risk of error in data entry. the manufacturer started a recall by letter dated august 2004 and states that half of the affected software cards were replaced in early august 2004.
Action
Check receipt of the letter dated August 2004, two attachments and Medtronic acknowledgment form. Identify and segregate any affected product in your inventory. Remove the infusion pump scheduler application card, and identify it with the software version following the instructions in attachment 1. If you have card programmers with software in AAA version 02, proceed as follows: (1) Complete the acknowledgment form, and return it by mail to Medtronic at the address below. (2) Contact Medtronic at (800) 328-0810, ext. 88608, USA or your local Medtronic representative outside the US to notify you of the number of affected cards in your inventory and to request updated versions. (3) Upon receipt of the updated cards, return the old cards to Medtronic by mail at the address below using the shipping envelope provided. If you need to use the infusion pump programmers before completing this recall, make sure during programming that you have selected the appropriate time field when entering the duration time or the interval time following the instructions in annex 2. If you already have AAD 02 version software updated on your infusion pump scheduler, or if you no longer have any affected products in your inventory, complete the recognition form, and return it to Medtronic by mail at the address below. Re-insert the AAD 02 card application following the instructions in Appendix 1, and continue using it. For more information, contact Medtronic by telephone at the above number or your local Medtronic representative.
Brazilian data is current through June 2018. All of the data comes from Anvisa, except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of data from the U.S. and Brazil.
Notes supplémentaires dans les données
For the Brazilian users of insulin pump and its disposables, this communication is purely informative since the product involved in this process, Quick-set Plus is not commercialized in Brazil, nor compatible with MMT-506 pumps, MMT-507 and MMT-508 used in the country.
Cause
Interruption of insulin flow in patients using this infusion set. this problem resulted in relevant complications, including hospitalizations.
Action
Medtronic Comercial Ltda. communicates to its clients and healthcare professionals that it is conducting a recall process for the Quick-setÒ Plus infusion set in the United States because of problems that may interrupt the flow of insulin in patients using this infusion set. This problem has resulted in relevant complications, including hospitalizations. Medtronic is asking patients outside of Brazil to contact their customer service center by phone (800) MINIMED (1-800-646-4633) - USA, to exchange any Quick-set Plus infusion set not used by other infusion set models currently marketed by Medtronic. In the event that continued use of the Quick-set Plus infusion set is required while replacement infusion sets are in transit, Medtronic recommends that patients monitor their blood glucose frequently and are prepared to treat any elevated glucose levels that may occur through injections. Patients are also being instructed to contact their health care providers if there are excessive increases or decreases in glucose levels or any other question relevant to their treatment. Information on changing the Quick-set Plus infusion set is available at www.minimed.com/QSP. This recall applies to all Paradigm Quick-Set Plus infusion set models (models: MMT-359S6, MMT -359S9, MMT-359L6 and MMT-359L9). This action only affects Quick-set Plus infusion sets; no other equipment or infusion set manufactured by Medtronic are involved in this recall.
Serbian data is current through February 2018. All of the data comes from ALIMS (Agencija za lekove i medicinska sredstva), except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Serbia.
Notes supplémentaires dans les données
Cause
The overall failure rate for the synchromed ii pump during the 78 months after installation is 2.4% if used to administer approved drugs, and 7.0% if used to administer unapproved drugs. the use of unapproved drugs may cause temporary or permanent downtime of the pump motor, which have been reported as a loss of therapy or a change in therapy. changes to therapy can cause serious injury and / or death.
Serbian data is current through February 2018. All of the data comes from ALIMS (Agencija za lekove i medicinska sredstva), except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Serbia.
Notes supplémentaires dans les données
Cause
The clinician refill reference card for synchromed® implantable infusion systems that was originally distributed with the january 2011 medical device correction related to pocket fills has been updated to align with new product labeling. the january 2011 medical device correction letter provided important reminders concerning the potential for a pocket fill during a synchromed ii or synchromed el implantable drug pump refill procedure, and important patient management recommendations. a pocket fill is the inadvertent injection of all or some of the prescribed drug into the patient's subcutaneous tissue, which includes the pump pocket, instead of the pump.
Serbian data is current through February 2018. All of the data comes from ALIMS (Agencija za lekove i medicinska sredstva), except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Serbia.
Notes supplémentaires dans les données
Cause
This letter provides important safety information and patient management recommendations regarding the unintended delivery of drug during the priming bolus function for the synchromed®implantable infusion pump. this unintended delivery of drug can contribute to patient overdose or underdose symptoms which may be clinically relevant.
Serbian data is current through February 2018. All of the data comes from ALIMS (Agencija za lekove i medicinska sredstva), except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Serbia.
Notes supplémentaires dans les données
Cause
Within the synchromed pump, feedthroughs are components that provide an electrically insulated path for current to flow from the electroniccircuitry to the motor. an electrical short can occur when ions from the drug solution and humidity permeate through the drug pathway tubing inside the pump and interact with the feedthrough over time. an electrical short circuit in a feedthrough may present as a motorstall or low battery reset/alarm and leadto a loss of or reduction in therapy which may result in the return of underlying symptoms and/or withdrawal symptoms. synchromed pump internal feedthrough shorts can lead to a loss of or reduction in therapy which may
result in a return of underlying symptoms and/or withdrawal symptoms.Patients receiving intrathecal
baclofen therapy are at risk for baclofen withdrawal syndrome, which can lead to a life threatening
condition if not promptly and effectively treated.Surgical revision to replace or remove the pumps may
be required for patients with pumps experiencing repeated motor stalls, low battery resets (with or
without safe state), or a premature elective replacement indicator.
Serbian data is current through February 2018. All of the data comes from ALIMS (Agencija za lekove i medicinska sredstva), except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Serbia.
Notes supplémentaires dans les données
Cause
The purpose of this letter is to inform you that medtronic diabetes has come to some knowledge of potential insulin delivery problems that could occur if insulin or other fluids come into contact with the connector interior in medtronic paradigm infusion sets.
Serbian data is current through February 2018. All of the data comes from ALIMS (Agencija za lekove i medicinska sredstva), except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Serbia.
Notes supplémentaires dans les données
Cause
Based on data collected from medtronic's implantable systems performance registry, the overall failure rate for a synchromed ii pump during the 78 months after installation is 2.4% if used to administer approved drugs, and 7.0% if used for administration of unapproved drugs. the use of unapproved drugs may cause temporary or permanent downtime of the pump motor, which have been reported as loss of therapy or change of therapy.
Serbian data is current through February 2018. All of the data comes from ALIMS (Agencija za lekove i medicinska sredstva), except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Serbia.
Notes supplémentaires dans les données
Cause
The synchromed priming bolus function is intended to quickly advance drug from the pump reservoir to
the catheter tip to allow for therapy initiation while the patient remains under medical supervision.
although drug is not intended to be delivered to the cerebrospinal fluid (csf) during the priming bolus,
mixing of the drug and non-drug (sterile water/csf) fluids occurs at the high infusion rates used during
a priming bolus. mixing results in the unintended delivery of drug prior to the end of the programmed
bolus, as well as dilution of some of the drug remaining in the catheter at the end of the bolus. patients
will receive unintended drug at a high rate of infusion in the csf during the priming bolus, and a period
of reduced concentration of drug will occur following the priming bolus. .
Serbian data is current through February 2018. All of the data comes from ALIMS (Agencija za lekove i medicinska sredstva), except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Serbia.
Notes supplémentaires dans les données
Cause
The clinician refill reference card for synchromed® implantable infusion systems that was originally distributed with the january 2011 medical device correction related to pocket fills has been updated to align with new product labeling. the january 2011 medical device correction letter provided important reminders concerning the potential for a pocket fill during a synchromed ii or synchromed el implantable drug pump refill procedure, and important patient management recommendations. a pocket fill is the inadvertent injection of all or some of the prescribed drug into the patient's subcutaneous tissue, which includes the pump pocket, instead of the pump. .
Austrian data is current through September 2018. All of the data comes from the Austrian Federal Office for Safety in Health Care (BASG), except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Austria.
Austrian data is current through September 2018. All of the data comes from the Austrian Federal Office for Safety in Health Care (BASG), except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Austria.