Events

Rappel de Device Recall Volumetric 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 Walkmed Infusion 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
    56750
  • Classe de risque de l'événement
    Class 1
  • Numéro de l'événement
    Z-0307-2011
  • Date de mise en oeuvre de l'événement
    2010-06-17
  • Date de publication de l'événement
    2010-11-05
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2012-03-14
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=94445
  • 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
    Infusion Pump - Product Code FRN
  • Cause
    Pump door may be in a near shut position, but unlatched, and the "door open" alarm may not sound.
  • Action
    All customers were notified by letter on 06/17/2010, describing the affected product and advising them of the possible malfunctioning alarm in the case a user does not follow the instructions as specified in the Triton Operation Manual. The letter also reminded all users to follow the procedures in the IFUs. The firm stated that it was best if customers re-educated all nurses on the proper door closure procedure to help prevent the potential bypass issue from occurring. Attached to the letter were two pages explaining the proper process for closing the pump door. Follow-up phone calls were made to coordinate an upgrade to all affected pumps. Questions or concerns should be directed to Ross Kurz at 720-531-4933.

Device

Device Recall Volumetric Infusion Pump
  • Modèle / numéro de série
    Serial numbers: 1 thru 500, TR1041 through TR2559.
  • Classification du dispositif
    General Hospital and Personal Use Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Nationwide Distribution -- AL, CA, FL, and PA.
  • Description du dispositif
    WalkMed Triton Pole Mount Infusion Pump, Catalog 300000. || Indicated for delivering infusions of medications, as well as providing total parenteral nutrition, and patient controlled analgesia.
  • Manufacturer
    Walkmed Infusion LLC

Manufacturer

Walkmed Infusion LLC
  • Adresse du fabricant
    Walkmed Infusion LLC, 96 Inverness Dr E Ste N, Centennial CO 80112-5311
  • Société-mère du fabricant (2017)
    Walkmed Infusion LLC
  • Source
    USFDA