Events

Rappel de Device Recall Baxter 6060 & Sabratek 6060 Homerun MultiTherapy 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
    34020
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-0412-06
  • Date de mise en oeuvre de l'événement
    2005-11-14
  • Date de publication de l'événement
    2006-01-28
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2007-06-19
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=42919
  • 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
    Failures within the pca profile as well as incidents resulting in interruptions of therapy in various profiles.
  • Action
    Baxter sent recall letters dated 11/14/05 to all of their 6060 pump customers on the same date via DHL overnight delivery. The accounts were informed of the reports of failures within the PCA profile and interruptions of therapy in various profiles. Due to the obsolescence of certain critical components, Baxter is conducting a controlled removal of all 6060 pumps from the market. Baxter will coordinate with customers individually to ensure a smooth transition to a substitute device. Baxter provided interim instructions to discontinue use of the PCA profile to avoid over infusion or non-delivery conditions, and to discontinue the use of the pump for therapies where interruption of the infusion could cause immediate patient harm. Baxter representatives telephoned each account within 48 hours of the letter, and visited them within a week to help the customers transition to other infusion pumps. A press release issued on 11/15/05. Baxter sent a follow-up recall letter to the accounts on 6/20/06, informing them that service repairs for the 6060 Infusion Pump will cease after 12/31/06, and compensation requests cannot be processed for pumps received after 12/31/06. Production of sets for the 6060 will cease on 10/1/06, and will not be available after 12/31/06. The accounts were requested to complete and fax back to Baxter the enclosed reply form, indicating the current inventory of 6060 pumps remaining at the facility.

Device

Device Recall Baxter 6060 & Sabratek 6060 Homerun MultiTherapy Infusion Pump
  • Modèle / numéro de série
    All serial numbers of all product codes
  • Classification du dispositif
    General Hospital and Personal Use Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Nationwide and internationally to Belgium, Germany, Finland, France, the United Kingdom, Ireland, Sweden, Norway, Canada, Japan, New Zealand and Australia.
  • Description du dispositif
    Baxter 6060 Multi-Therapy Infusion Pump, product codes 2M9832, 2M9832P and 2M9832R, and Sabratek 6060 Homerun Infusion Pumps, product codes 606000, 606000-40, 606000-40L, and 606000-40I; Manufactured by an affiliate of Baxter Healthcare Corp., Deerfield, IL 60013 USA, made in Singapore
  • Manufacturer
    Baxter Healthcare Corp.

Manufacturer

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