Events

Rappel de Device Recall Colleague 3 and Colleague 3 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
    34096
  • Classe de risque de l'événement
    Class 1
  • Numéro de l'événement
    Z-0445-06
  • Date de mise en oeuvre de l'événement
    2005-12-13
  • Date de publication de l'événement
    2006-01-31
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2011-11-30
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=43107
  • 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 Pumps - Product Code FRN
  • Cause
    Interruption of therapy due to battery undercharging, the generation of air-in-line alarms due to iv administration set tugging, and gearbox wear; and underinfusion due to misalignment of the pump head components.
  • Action
    Baxter sent the 12/13/05 Urgent Device Correction letter to all Colleague Infusion Pump customers, to the attention of the Director of Nursing and the Biomedical Engineer, via first class mail to alert them to additional problems with the pump that may interrupt therapy. These issues include battery undercharging, generation of false air detected alarms due to IV administration set tugging, gearbox wear, underinfusion and non-detection of upstream occlusions. The letters included mitigating instructions to reduce the occurrence of these potential problems, and included a copy of the Battery Usage Guide, Infusion Management Guide, and the March 17, 2005 Buretrol Set Urgent Device Correction letter to be provided to all users of the Colleague pump. Baxter informed the accounts that they would be notified when the new release of the Colleague Volumetric Infusion Pump Operator''s Manual is available. Any questions were directed to Baxter''s Medication Delivery Services at 1-800-843-7867.

Device

Device Recall Colleague 3 and Colleague 3 CX Volumetric Infusion Pumps
  • Modèle / numéro de série
    all serial numbers
  • Classification du dispositif
    General Hospital and Personal Use Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Worldwide distribution: USA, Puerto Rico, United Kingdom, Canada, Brazil, Hong Kong, Taiwan, Turkey, Kuwait, South Africa, Chile, Saudi Arabia, Korea, Mexico, Colombia, New Zealand, the Bahamas, Belgium, El Salvador, Guatemala, Honduras, Israel, Lebanon, Panama, the Philippines and the United Arab Emirates.
  • Description du dispositif
    Baxter Colleague Triple Channel Volumetric Infusion Pumps; Baxter Healthcare Corporation, Medication Delivery Division, Deerfield, IL 60015 U.S.A., Made in Singapore; product codes 2M8153, 2M8153R, BRM8153(Brazilian Portugese), DNM8153(French), HNM8153(German), PNM8153(Spanish), CNM8153(Swedish), GNM8153(Danish), TRM8153(Turkish), WNM8153(Dutch) ,2M8163, 2M8163R
  • Manufacturer
    Baxter Healthcare Corp.

Manufacturer

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