Events

Rappel de Baxter SIGMA Spectrum Infusion Pump with Master Drug Library (Version 6)

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 Baxter Healthcare Corporation.

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
    79177
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-0971-2018
  • Date de mise en oeuvre de l'événement
    2017-10-06
  • 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=161516
  • 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
    Certain infusion pumps may exhibit excessive wear of the pumping mechanism caused by a lack of lubrication, this could affect the occlusion of the tubing and result in over- or under-infusion.
  • Action
    An Urgent Medical Device Correction, dated October 6, 2017, was sent to customers. The letter described the problem, identified the affected device, discussed the hazard involved, and action to be taken. Customers were asked to locate the affected products at their facility. Customers should continue to follow the instructions in document 41394 Rev. A, PREVENTIVE MAINTENANCE, for their entire fleet of pumps. Baxter will inspect affected pumps. To arrange for return of devices that have failed the flow rate accuracy test, contact Baxter Healthcare Medina. If you are a dealer, wholesaler, or distributor/reseller that distributed any product to other facilities, please notify your customers of this Urgent Medical Device Correction. If there are additional questions, customers can contact their Baxter Sales Rep or Baxter Healthcare Medina at 800-356-3454.

Device

Baxter SIGMA Spectrum Infusion Pump with Master Drug Library (Version 6)
  • Modèle / numéro de série
  • Classification du dispositif
    General Hospital and Personal Use Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Worldwide Distribution - US, including the District of Columbia, Puerto Rico, and Canada.
  • Description du dispositif
    Baxter SIGMA Spectrum Infusion Pump with Master Drug Library (Version 6) (GTIN 00085412091570); Model Numbers: 35700BAX and 35700ABB. || Intended to be used for the controlled administration of fluids.
  • Manufacturer
    Baxter Healthcare Corporation

Manufacturer

Baxter Healthcare Corporation
  • Adresse du fabricant
    Baxter Healthcare Corporation, 711 Park Ave, Medina NY 14103-1036
  • Société-mère du fabricant (2017)
    Baxter International
  • Source
    USFDA