Events

Rappel de Device Recall Colleague Single Channel 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
    30381
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-0342-05
  • Date de mise en oeuvre de l'événement
    2004-11-04
  • Date de publication de l'événement
    2004-12-22
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2011-02-02
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=35771
  • 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
    A software anomaly causes a failure alarm code 12:303 which audibly alarms and stops the function of all channels in use. this causes an interruption in therapy, which may result in a risk to the patient.
  • Action
    Baxter sent Urgent Device Correction letters dated 11/4/04 to the direct accounts to the attention of the Director of Biomedical Engineering on the same date. The letters informed the accounts of the 12:303 failure and possible interruption of patient therapy when it occurs. They were informed that new software was available to address the failure alarm code with the infusion pumps, and that the software also included updates to the predefined label library and the addition of a text message 'Close regulating roller clamp' to the manual tube release pop-up message. The software is being installed on all single and triple channel Colleague infusion pumps as they are processed through Baxter''s depot repair centers for other repair actions or routine maintenance. An Operator''s Manual Addendum was included with the letter to reflect the changes to the label library and the manual tube release pop-up message. The accounts were requested to complete the attached reply form and return it via fax to Baxter. The completed form acknowledges receipt of the recall letter, verifies the model numbers and serial numbers of the pumps at the facility and indicates the number of revised software installation kits needed by self-service customers. Any questions were directed to Baxter at 1-800-843-7867.

Device

Device Recall Colleague Single Channel 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
    Nationwide and internationally to Australia, the Bahamas, Belgium, Brazil, Canada, Colombia, El Salvador, Guatemala, Honduras, Israel, Lebanon, Mexico, New Zealand, Panama, the Philippines, Saudi Arabia, South Africa, Taiwan, Turkey, United Arab Emirates and the United Kingdom.
  • Description du dispositif
    Colleague Single Channel Volumetric Infusion Pumps, product code 2M8151and 2M8151R; Baxter Healthcare Corporation, Deerfield, IL 60015 U.S.A., Made in Singapore; monochrome display screen
  • Manufacturer
    Baxter Healthcare Corp.

Manufacturer

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