Events

Rappel de Device Recall Medfusion Syringe Pump, 3500 Series

Selon U.S. Food and Drug Administration, ce/cet/cette rappel concerne un dispositif en/au/aux/à United States qui a été fabriqué par Smiths Medical ASD Inc..

Qu'est-ce que c'est?

Une correction ou un retrait opéré par un fabricant afin de répondre à un problème causé par un dispositif médical. Les rappels surviennent lorsqu'un dispositif médical est défectueux, lorsqu'il pourrait poser un risque pour la santé, ou les deux à la fois.

En savoir plus sur les données ici
  • Type d'événement
    Recall
  • ID de l'événement
    77761
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-0314-2018
  • Date de mise en oeuvre de l'événement
    2017-08-22
  • Statut de l'événement
    Open, Classified
  • Pays de l'événement
    United States
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=157840
  • Notes / Alertes
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Notes supplémentaires dans les données
    Pump, infusion - Product Code FRN
  • Cause
    Potential for the syringe barrel clamp mechanism to loosen, decreasing the pump's ability to accurately detect the diameter of the syringe barrel, resulting in the unit to initiate the "invalid syringe size" alarm.
  • Action
    The firm,Smiths Medical, sent an, "Urgent Medical Device Recall" Amendment Notice (amending the original August 2017) concerning invalid syringe size alarms on certain Medfusion¿ Syringe Pump Model Series 3500 and 4000. The letter described the product, problem, actions to be to taken, and updated changes, as follows: 1. Locate the affected Medfusion¿ Syringe Pump(s) by referring to the list of affected devices on the attached Urgent Medical Device Recall Notice Response Form. This form provides the specific serial number(s) your organization purchased. Each pump has a unique serial number which can be found on the label located on the bottom of the pump. If you have ten (10) or more affected pumps in your possession, please select one of the following repair options: a. Repair at your Facility: Contact Smiths Medical to schedule a technician to visit your facility and complete the necessary repairs onsite. b. Send to Smiths Medical for Repair: Impacted pumps may be sent to a Smiths Medical Service Center, where repairs will be completed. A prepaid shipping label will be provided. Repairs will be completed within ten (10) business days of receipt. Loaner units are available upon request. c. NEW OPTION - Biomedical Department self-repair at your Facility: Contact Smiths Medical to receive the necessary parts and work instruction to have your biomed team complete the necessary repairs onsite. If you have nine (9) or fewer affected pumps in your possession: a. Send to Smiths Medical for Repair: Impacted pumps may be sent to a Smiths Medical Customer Service Center, where repairs will be completed. A prepaid shipping label will be provided. Repairs will be completed within ten (10) business days of receipt. Loaner units are available upon request. b. NEW OPTION - Biomedical Department Self-Repair at Your Facility: Contact Smiths Medical to receive the necessary parts and work instruction to have your biomed team complete the necessary repairs onsite. To initi

Device

Device Recall Medfusion Syringe Pump, 3500 Series
  • Modèle / numéro de série
    Model No. 3500; Reference No. 3500-0600-51
  • Classification du dispositif
    General Hospital and Personal Use Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Worldwide Distribution: US (Nationwide) and countries of: Canada, Great Britain, Panama, Germany, India, Philippines, and Oman.
  • Description du dispositif
    Medfusion, Syringe Infusion Pump, Software Version 6 (V6), Rx Only, Manufactured by Smiths Medical ASD, Inc., 1500 Eureka Park, Lower Pemberton, Ashford, Kent, TN25 4BF, UK. || In the administration of fluids requiring precisely controlled infusion rates including blood or blood products, lipids, drugs, antibiotics, enteral solutions and other therapeutic fluids.
  • Manufacturer
    Smiths Medical ASD Inc.

Manufacturer

Smiths Medical ASD Inc.
  • Adresse du fabricant
    Smiths Medical ASD Inc., 6000 Nathan Ln N, Minneapolis MN 55442-1690
  • Société-mère du fabricant (2017)
    Smiths Group Plc
  • Source
    USFDA