Events

Rappel de Device Recall BodyGuard

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 CME America, LLC.

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
    70294
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-1126-2015
  • Date de mise en oeuvre de l'événement
    2015-01-16
  • Date de publication de l'événement
    2015-02-19
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2017-03-31
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=132890
  • 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
    Cme america is recalling the bodyguard and bodyguard 323 infusion pumps due to the potential for an over delivery.
  • Action
    CME America sent an "Urgent Medical Device Recall" letter dated January 16, 2015, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. Required Action for Users: To date there have been no reports of adverse events or serious injury. However, there is the potential for serious injury or death. CME America recommends that you DO NOT use the BodyGuard 323 pump for PCA infusion. If your devices are currently in use, be sure that the programmed parameters DO NOT involve a patient controlled bolus dose less than 0.1 miln volume (translated into meg or mg). Follow-up Actions by CME America: CME America has identified the root cause of this issue and is recommending installation of a new version of software, USA36B4, for affected BodyGuard 323 infusion pumps. This software is identical to the previously released version, USA36A4.2. However the designation of B4 in the software name will identify updated software in each device. CME America will contact all affected customers within 60 days to initiate the scheduling process for the remediation. Your assistance is appreciated and necessary to prevent use and facilitate remediation of the recalled product. CME America can address any questions regarding the recalled product by calling the CME America recall line at 720-839-2391.

Device

Device Recall BodyGuard
  • Modèle / numéro de série
    All product with USA36A4.4 version of software affected
  • Classification du dispositif
    General Hospital and Personal Use Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Worldwide Distribution - Nationwide Distribution and VA/military/govt consignees and the country of Canada.
  • Description du dispositif
    BodyGuard 323 pump, models || 100-510PXSI, 100-516PXS, 100-517PXS, 100-518PXS, || 100-603XSA and 100-603XSAP
  • Manufacturer
    CME America, LLC

Manufacturer

CME America, LLC
  • Adresse du fabricant
    CME America, LLC, 14998 W 6th Ave, Golden CO 80401-6587
  • Société-mère du fabricant (2017)
    CME America, LLC
  • Source
    USFDA