Events

Rappel de Device Recall Colleague and Colleague CX Volumetric Infusion Pumps

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
    31188
  • Classe de risque de l'événement
    Class 1
  • Numéro de l'événement
    Z-1543-05
  • Date de mise en oeuvre de l'événement
    2005-02-25
  • Date de publication de l'événement
    2005-09-23
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2011-02-16
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=37330
  • 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
    Swelling of the sealed lead-acid batteries in the infusion pump can cause internal pump damage, and excessive battery discharge can damage the batteries if the pump is left on battery power for an extended period of time after teh battery depleted alarm occurs.
  • Action
    Baxter sent letters dated 02/25/05 to all Colleague infusion pump customers to provide them with important supplemental information to the letter dated 1/21/03 (Z-929-1), regarding sealed lead-acid batteries used in the Colleague family of infusion pumps, dealing with swollen batteries and excessive deep discharge. The 2/25/05 letter reiterated the battery service life, replacement and pump storage conditions which were listed in the 1/21/03 letter, and informed the users that current production pumps have an overcurrent protection circuit in the battery harness to help protect the batteries from overcurrent damage and swelling during charging, and advised them of the availability of the battery harness. The letters also provided information to prevent excessive discharge, and advised them that software updates will become available later in 2005. An Operator's Manual Addendum was also included with the 2/25/05 letter, replacing chapter 7 of the manual dealing with Maintenance and Service. Any questions were directed to Baxter's Medication Delivery Services at 1-800-843-7867.

Device

Device Recall Colleague and Colleague CX Volumetric Infusion Pumps
  • Modèle / numéro de série
    product codes 2M8151 and 2M8151R: all serial numbers below 13120001CS;  product codes 2M8161 and 2M8161R: all serial numbers below 13110181CC
  • Classification du dispositif
    General Hospital and Personal Use Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Nationwide including Puerto Rico, and internationally to Taiwan, Canada, Chile, Korea, Colombia, New Zealand, China, Hong Kong, Brazil, Turkey and Saudi Arabia.
  • Description du dispositif
    Baxter Colleague Single Channel Volumetric Infusion Pumps; Baxter Healthcare Corporation, I.V. Systems Division, product codes 2M8151, 2M8151R, 2M8161, 2M8161R
  • Manufacturer
    Baxter Healthcare Corp.

Manufacturer

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