Alerte Ou Avis De Sécurité sur All T34 ambulatory syringe pumps

Selon Medicines and Healthcare products Regulatory Agency, ce/cet/cette alerte ou avis de sécurité concerne un dispositif en/au/aux/à United Kingdom qui a été fabriqué par Caesarea Medical Electronics.

Qu'est-ce que c'est?

Les avis de sécurité sont des communications que les fabricants de dispositifs médicaux ou leurs représentants font parvenir en particulier aux travailleurs du secteur médical, mais aussi aux utilisateurs de ces dispositifs. Les avis de sécurité concernent les actions entreprises quant aux dispositifs présents sur le marché et peuvent inclure des rappels et des alertes.

En savoir plus sur les données ici
  • Type d'événement
    Safety alert / Field Safety Notice
  • Numéro de l'événement
    MDA/2018/010
  • Date
    2018-03-28
  • Date de publication de l'événement
    2018-03-28
  • Pays de l'événement
  • Source de l'événement
    MHRA
  • URL de la source de l'événement
  • Notes / Alertes
    Data from the United Kingdom is current through April 2019. All of the data comes from the Medicines and Healthcare products Regulatory Agency, 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 the United Kingdom.
  • Notes supplémentaires dans les données
    The manufacturer has identified that there can be a +/- 2mm overall size difference between battery brands used with CME’s T34 ambulatory syringe pumps.This could result in battery movement within the battery housing leading to a possible loss of connection. This may result in the pump shutting down.Be aware that if the pump’s battery connectors and/or housing are inadvertently damaged during these checks, and the pump is outside of the warranty period, the manufacturer may charge for pump repair/replacement.
  • Cause
    Manufactured by caesarea medical electronics (cme) ltd – a variation in battery size can cause problems with connections in the battery housing. (mda/2018/010).

Device

Manufacturer