Events

Avis De Sécurité sur BBraun Perfusor Space Infusion Pump

Selon Health Products Regulatory Authority, ce/cet/cette avis de sécurité concerne un dispositif en/au/aux/à Ireland qui a été fabriqué par B. Braun Melsungen AG.

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
    Field Safety Notice
  • Numéro de l'événement
    SN2014(17)
  • Date
    2014-04-08
  • Pays de l'événement
    Ireland
  • Source de l'événement
    HPRA
  • URL de la source de l'événement
    http://www.hpra.ie/homepage/medical-devices/safety-information/safety-notices/item?t=/bbraun-perfusor-space-infusion-pump.-priority-2---warning&id=85cff925-9782-6eee-9b55-ff00008c97d0
  • Notes / Alertes
    "Irish data is current through April 2019. All of the data comes from the Health Products Regulatory Authority (Ireland), 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 data from the U.S. and Ireland."
  • Notes supplémentaires dans les données
  • Cause
    The irish medicines board (imb) wishes to remind users of a field safety notice (fsn) issued by b. braun in december 2013. b. braun has identified a risk that when the perfusor space pump is used with an aged battery, that the pump may not have sufficient current to perform a syringe change, despite the battery indicator on the pump showing full charge.  the issue can only occur when the pump is not connected to the mains and presents a risk when the pump is used on battery only.
  • Action
    The IMB would like to remind users to:  (1) Follow the instructions outlined by the manufacturer in the FSN attached.  (2) Identify any batteries (or battery packs) of four years or older.  (3) Contact your Biomedical Engineering Department to arrange for replacement or testing of the battery (battery pack), as outlined in the device service manual.  (4) Always have an additional pump available for infusion of critical medications and during transport of patients.  (5) Forward this IMB Safety Notice to all those within your organisation that need to be aware of this information.

Device

BBraun Perfusor Space Infusion Pump
  • Modèle / numéro de série
  • Description du dispositif
    BBraun Perfusor Space Infusion Pump. Priority 2 - Warning
  • Manufacturer
    B. Braun Melsungen AG

Manufacturer

B. Braun Melsungen AG