Events

Rappel de Sigma Spectrum VOLUMETRIC INFUSION PUMP

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 Sigma International General Medical Apparatus, Llc.

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
    56833
  • Classe de risque de l'événement
    Class 1
  • Numéro de l'événement
    Z-0146-2011
  • Date de mise en oeuvre de l'événement
    2010-09-15
  • Date de publication de l'événement
    2010-11-05
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2017-06-28
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=94606
  • 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
    Infusion pump - Product Code FRN
  • Cause
    The infusion pumps have the potential to fail causing inaccurate flow conditions during use. these conditions range from back flow to free flow, which could result in over-infusion.
  • Action
    Urgent: Medical Device Recall Notification letters and forms (dated 9/14/10) were sent to the consignees via Certified Mail on/about 9/15/10. The letters inform the consignees of the recall of the pumps since these units may fail suddenly causing inaccurate flow conditions during use, ranging from back flow to over-infusion, including free flow. Consignees are instructed to check their inventory to verify whether their serial numbers fall within the range of pumps being recalled. Due to possible bearing failure, SIGMA is taking the precautionary measure of servicing or replacing all affected Spectrum Infusion Pumps and is requiring the return of the recalled devices to its facility. SIGMA has provided the following instructions for users: (1) Do not use the affected Spectrum Infusion Pumps on patient populations where inaccurate flow, ranging from back flow to over-infusion, including free flow, could result in serious adverse health consequences or death. (2) Do not use on neonatal patients. -- If the user facility has no acceptable alternative methods for delivering therapy, the user should weigh the risks and benefits for the continued use of the affected pumps. If you must use these pumps, SIGMA recommends the following actions which may mitigate the risk. (1) for pediatric and adult patients, an add-on Buretrol may limit the amount of an over-infusion if the failure occurs. Always follow the Buretrol manufacturer's instructions. (2) consider using air-eliminating filters. Under free flow conditions pumps cannot stop fluid flow. If air is in the line with fluid, the air will also infuse. (3) Frequently observe that the drip rate (mL/hr) compares to the programmed pump flow rate. Also, make an observation of the container volume to make sure it is correct. If a discrepancy is observed, immediately remove the pump from service and treat the patient as appropriate. There are additional instructions to Asset Management Customers: SIGMA requests that each A

Device

Sigma Spectrum VOLUMETRIC INFUSION PUMP
  • Modèle / numéro de série
  • Classification du dispositif
    General Hospital and Personal Use Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Nationwide Distribution
  • Description du dispositif
    Sigma Spectrum VOLUMETRIC INFUSION PUMP, with or without Master Drug Library, Part Number 35700 -- || Common/Classification Name: Infusion Pump --Class 2 medical device -- SIGMA LLC, Medina, NY 14103 -- Shipping box label: Infusion Pump SIGMA Model 35700 (with accessories), SIGMA International, Inc. Medina, NY 14103 ** Serial Number: XXXXXX. || To be used in a healthcare facility in an IV pole mounted configuration or carried by the user in an ambulatory manner.
  • Manufacturer
    Sigma International General Medical Apparatus, Llc

Manufacturer

Sigma International General Medical Apparatus, Llc
  • Adresse du fabricant
    Sigma International General Medical Apparatus, Llc, 711 Park Avenue, Medina NY 14103-1036
  • Société-mère du fabricant (2017)
    Baxter International
  • Source
    USFDA