Events

Alerte Ou Avis De Sécurité sur Intra-aortic balloon pump (IABP)

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 Datascope Corp.

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
  • Date
    2017-10-03
  • Date de publication de l'événement
    2017-10-03
  • Pays de l'événement
    United Kingdom
  • Source de l'événement
    MHRA
  • URL de la source de l'événement
    https://www.gov.uk//drug-device-alerts/intra-aortic-balloon-pump-iabp-maquet-datascope-cs100-cs100i-and-cs300-potential-for-interruption-or-delay-to-therapy-of-critically-ill-patients
  • 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
    Manufactured by maquet/gettinge – a false blood detection alarm and/or fluid ingress could result in the failure of therapy to patients.
  • Action
    Note: this MDA is for a different issue to the one described in MDA/2017/027 issued 24 August 2017.Identify all affected devices – see the manufacturer’s Field Safety Notice (FSN) dated 17 July 2017. Products distributed from 24 March 2003 to 16 June 2017 inclusive are affected. Use an alternative IABP or an alternative therapy for treatment if available. If no alternative is available, undertake a risk assessment based on a clinical risk-benefit analysis. Affected devices which remain in use should be used in accordance with the manufacturer’s FSN. Contact Maquet to confirm receipt of the FSN and to schedule both the software and hardware updates to prevent false alarms and installation of gaskets to prevent fluid ingress.

Device

Intra-aortic balloon pump (IABP)

Manufacturer

Datascope Corp
  • Adresse du fabricant
    Maquet/Getinge Hari Rajendran Post Market Surveillance Manager SSU North Europe QRC/ EMEATelephone: 0191 519 6200hariraj.rajendran@getinge.com
  • Société-mère du fabricant (2017)
    Getinge AB
  • Source
    MHRA