Events

Rappel de Device Recall Colleague, Colleague CX and CXE Triple Channel 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
    50839
  • Classe de risque de l'événement
    Class 1
  • Numéro de l'événement
    Z-1038-2009
  • Date de mise en oeuvre de l'événement
    2009-01-23
  • Date de publication de l'événement
    2009-03-02
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2011-10-04
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=77461
  • 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
    Baxter has identified failure codes that lead to a delay or an interruption of therapy, hazards associated with improper cleaning, and damaged battery messages for the colleague infusion pumps.
  • Action
    Baxter Healthcare Corporation sent an "Urgent Device Correction" letter dated January 23, 2009 to all Colleague Infusion Pump customers, to the attention of the Vice President of Nursing with copies to the Chief Operating Officer, Director of Biomedical Engineering and Director of Risk Management to advise them of failure codes that lead to an interruption of therapy, hazards associated with improper cleaning, and damaged battery messages associated with the Colleague pumps. The letters listed the failure codes involved that lead to an interruption of therapy which could lead to serious injury and/or death; advised institutions to have contingency plans to verify that back-up pumps are available; and provided steps for addressing an interruption of therapy with any failure code. The letters also provided information about the hazards associated with improper cleaning of the pumps and instructions for addressing damaged battery messages. Customers were instructed to complete the attached Customer Reply Form acknowledging receipt of the letter and fax it to 888-569-1585. Direct questions to your local Baxter Representative or to Baxter Global Technical Services by calling 1-800-843-7867, Prompt 2, between 7AM and 5 PM Central Standard Time (CST).

Device

Device Recall Colleague, Colleague CX and CXE Triple Channel Infusion Pumps
  • Modèle / numéro de série
    All product numbers and all serial numbers.
  • Classification du dispositif
    General Hospital and Personal Use Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Worldwide including USA, Puerto Rico, Aruba, Australia, Austria, Bahamas, Bahrain, Belgium, Bermuda, Brazil, Canada, Cayman, Chile, China, Colombia, Curacao, Denmark, Dominican Republic, El Salvador, Finland, France, Germany, Greece, Guatemala, Hong Kong, Honduras, India, Ireland, Israel, Italy, Jamaica, Korea, Kuwait, Lebanon, Macedonia, Malaysia, Malta, Mexico, Netherlands, New Zealand, Nicaragua, Norway, Oman, Panama, Peru, Philippines, Qatar, Saudi Arabia, Singapore, Slovakia, Slovenia, South Africa, Spain, Sweden, Switzerland, Taiwan, Thailand, Trinidad, Turkey, United Arab Emirates, United Kingdom and Venezuela.
  • 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, 2M8163, 2M9163, DNM8153, DNM9163, BRM8153, BRM8153T, BRM8153RT, PNM8153, PNM8153T, PNM8153RT, CNM8153, GNM8153, HNM8153, TRM8153 and WNM8153. || Electronic infusion pumps are indicated for continuous or intermittent delivery of solution through clinically acceptable routes of administration, such as intravenous (IV), intra-arterial (IA), subcutaneous, epidural or irrigation of fluid spaces applications.
  • Manufacturer
    Baxter Healthcare Corp.

Manufacturer

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