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
    33999
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-0411-06
  • Date de mise en oeuvre de l'événement
    2005-11-07
  • 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=42885
  • 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
    Possible shorting of some printed circuit boards could result in a possible interruption of therapy or cause the pump to fail the power-on self test.
  • Action
    Baxter sent Urgent Device Correction letters dated 11/7/05 to the user accounts, advising them of the potential for the circuit boards in the 6060 pump to fail due to a problem that occurred in the supplier's manufacturing process. The letter included a list of 6060 pump serial numbers sent to the user that may contain an affected circuit board. To mitigate safety risks to the patient, Baxter advised customers to immediately discontinue use of the pump for therapies where interruption of the infusion could cause immediate patient harm. In addition, the pump is not to be used if it fails the Power-On Self Test. The accounts were instructed to contact Baxter Medication Delivery Services at 1-800-843-7867 for information regarding the return process for the affected 6060 pumps for correction. Baxter sent follow-up letters dated 2/16/06 to the accounts, to the attention of the Director of Biomedical Engineering, informing them that Baxter has sufficient quantities of replacement circuit boards to begin the repairs. The accounts were requested to review the enclosed list of serial numbers for accuracy and telephone Baxter at 1-800-843-7867 to schedule the return of any 6060 Infusion Pump that requires replacement of the circuit board.

Device

Device Recall Baxter 6060 & Sabratek 6060 Homerun MultiTherapy Infusion Pump
  • Modèle / numéro de série
    product codes 2M9832, 2M9832P and 2M9832R; product codes 606000, 606000-40, 606000-40L, and 606000-40I; 2M9832: serial numbers 501001HR-501263HR, 502001HR-502156HR, 503001HR-503155HR, 505001HR-505210HR, 507001HR-507054HR, 502001HG-502060HG, 503001HG-503048HG, 505001HG-505276HG, 506001HG-506180HG, 501001HJ-501072HJ, 502001HJ-502072HJ, 503001HJ-503060HJ, 504001HJ-504060HJ, 505001HJ-505060HJ, 501001HW-501020HW, 502001HW-502024HW, 501001HF-501012HF, 502001HF-502024HF
  • Classification du dispositif
    General Hospital and Personal Use Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Nationwide, and internationally in France, Germany, Sweden and teh United Kingdom.
  • 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