Events

Rappel de SPECTRUM INFUSION PUMP WITH MASTER DRUG LIBRARY

Selon Health Canada (via FOI), ce/cet/cette rappel concerne un dispositif en/au/aux/à Canada qui a été fabriqué par BAXTER CORPORATION.

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
    15297
  • Classe de risque de l'événement
    I
  • Date de mise en oeuvre de l'événement
    2016-09-28
  • Pays de l'événement
    Canada
  • Source de l'événement
    HC
  • Notes / Alertes
    Canadian data is current through March 2018. All of the data comes from Health Canada, except for the categories Manufacturer Parent Company and Product Classification.
    The Parent Company and the Product Classification were added by ICIJ.
    The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Canada.
  • Notes supplémentaires dans les données
  • Cause
    Baxter corporation is issuing a device correction for the sigma spectrum infusion pump with master drug library (spectrum infusion pump) in order to replace speakers installed in pumps that have an increased potential to fail prematurely. the speaker is intended to generate audible tones during each keystroke and during alarm conditions. however some speakers have a variation in their internal wiring that increases the potential for the speaker to fail prematurely. spectrum infusion pumps with non-functional speakers will continue to display visual alarm indications and will otherwise continue to operate as intended. before using an affected spectrum infusion pump users should confirm the generation of an audible tone as instructed in the device operator manual.

Device

SPECTRUM INFUSION PUMP WITH MASTER DRUG LIBRARY
  • Modèle / numéro de série
    Model Catalog: 35700BAX (Lot serial: > 10 contact manufacturer); Model Catalog: 35700BAX2 (Lot serial: > 10 contact manufacturer)
  • Classification du dispositif
    General Hospital and Personal Use Devices
  • Description du dispositif
    SPECTRUM INFUSION PUMP WITH MASTER DRUG LIBRARY (V6 & V8)
  • Manufacturer
    BAXTER CORPORATION

Manufacturer

BAXTER CORPORATION