Events

Avis De Sécurité sur H-1200 Fast Fluid Warmer with integrated Air Detector / Clamp and H-31B and H-30 Air Detector / Clamp Accessory

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

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
    SN2008(02)
  • Date
    2008-01-31
  • 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=/h-1200-fast-fluid-warmer-with-integrated-air-detector-clamp-and-h-31b-and-h-30-air-detector-clamp-accessory&id=0594f825-9782-6eee-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 risk of air embolism if the power of the fluid warmer unit is interrupted either manually or through power failure during an air detection event.
  • Action
    Further to this incident the Irish Medicines Board (IMB) advises users to discontinue the use of the device until further notice.   Identify and quarantine affected devices until further notice.   If no alternative fluid warmer is available, ensure users are aware of the advice provided in the manufacturer’s customer letter (copy attached as appendix 1) and ensure that the quick reference guide is attached to all affected devices.   Contact the manufacturer to request a copy of quick reference guide if not attached to all affected devices

Device

H-1200 Fast Fluid Warmer with integrated Air Detector / Clamp and H-31B and H-30 Air Detector / C...
  • Modèle / numéro de série
  • Description du dispositif
    H-1200 Fast Fluid Warmer with integrated Air Detector / Clamp and H-31B and H-30 Air Detector / Clamp Accessory
  • Manufacturer
    Smiths Medical

Manufacturer

Smiths Medical