Events

Alerte Ou Avis De Sécurité sur Perfusor Space infusion pump

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 B Braun.

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
  • ID de l'événement
    MDA/2013/080
  • Numéro de l'événement
    CON341212
  • Date de publication de l'événement
    2013-11-21
  • Pays de l'événement
    United Kingdom
  • Source de l'événement
    MHRA
  • URL de la source de l'événement
    https://webarchive.nationalarchives.gov.uk/20150113054913/http://www.mhra.gov.uk/PrintPreview/MedicalDeviceAlertSP/CON341212?tabName=allTabs
  • 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
  • Cause
    Risk of interruption of therapy when changing syringe. if an aged battery (4 years or older) is used, the pump may not have sufficient power to perform a syringe change, despite the battery indicator on the pump showing a full charge. this could lead to the therapy unexpectedly stopping. the problem does not arise if the pump is plugged into the mains electrical supply. please see the manufacturer’s field safety notices (technical or clinical).
  • Action
    Ensure all relevant staff are aware of the problem and of the guidance in the Field Safety Notice. Identify and replace or test any batteries that are 4 years or older as detailed in the service manual. During transportation of patients: Do not use a pump with aged batteries, if possible. In all cases make sure a spare battery or pump is available, as detailed in the user manual. Actions by All those responsible for the use or maintenance of the devices.

Device

Perfusor Space infusion pump
  • Modèle / numéro de série
  • Description du dispositif
    Perfusor Space infusion pump. The service manual , page 6-3, provides guidance on the identification of pumps with affected batteries.
  • Manufacturer
    B Braun

Manufacturer

B Braun