Events

Rappel de Device Recall Baxter FloGard 6201 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 Baxter Healthcare Corp..

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
    57334
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-0933-2011
  • Date de mise en oeuvre de l'événement
    2010-11-17
  • Date de publication de l'événement
    2011-01-21
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2011-03-16
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=95890
  • 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
    The flogard infusion pump was released from service without having the current leakage test performed. this could lead to the patient/user to receive an electrical shock.
  • Action
    The firm, Baxter, telephoned the one customer on November 17, 2010, informing them that electrical safety testing was not performed on their FloGard pump serial number 11091330FA during the last service. Since the test was not conducted on the pump, the device may not function as designed and could lead to a hazard of electrical shock. Baxter requested that they locate the pump and remove it from use as soon as possible. Baxter advised the customer that a Baxter Field Service Engineer would be sent to their facility to perform electrical safety testing or alternatively, the customer may choose to send the pump to Baxter for testing. If you have any questions regarding this information, please contact Vice President, Quality, GIS at 847-270-5507.

Device

Device Recall Baxter FloGard 6201 Volumetric Infusion Pump
  • Modèle / numéro de série
    product code 2M8063, serial number 11091330FA
  • Classification du dispositif
    General Hospital and Personal Use Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Nationwide distribution: WA only
  • Description du dispositif
    Baxter FloGard 6201 Volumetric Infusion Pump. Baxter Healthcare Corporation, Medication Delivery Division. Product code 2M8063 || For delivery of intravenous solutions, drug solutions, enteral feedings and blood.
  • Manufacturer
    Baxter Healthcare Corp.

Manufacturer

Baxter Healthcare Corp.
  • Adresse du fabricant
    Baxter Healthcare Corp., Rt. 120 & Wilson Rd, Round Lake IL 60073
  • Source
    USFDA