Events

Alerte Ou Avis De Sécurité sur GemStar infusion system

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 Hospira.

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/2014/010
  • Numéro de l'événement
    CON392878
  • Date
    2014-03-13
  • Date de publication de l'événement
    2014-03-13
  • 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/CON392878?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 delay to patient therapy due to loss of audio alarms. the connection between the beeper subassembly and pump may fail so that only visual alarms will be available. the pump will only identify the beeper failure during ‘self-test’ whilst powering up, which will prevent it from being programmed or used. pumps that were previously fixed for this beeper failure may fail again.
  • Action
    Use an alternative pump, where available. If an alternative is not available, assess the risks and benefits of using the pump for each patient. Be aware of the MHRA’s advice on GemStar infusers in MDA/2013/078. Report any adverse incidents involving these pumps to the MHRA. Action by: All medical, nursing and technical staff involved in the use of these pumps.

Device

GemStar infusion system
  • Modèle / numéro de série
  • Description du dispositif
    Infusion pumps: GemStar infusion system. List numbers: 13000, 13100, 13150. The list numbers can be found on the rear of the device.
  • Manufacturer
    Hospira

Manufacturer

Hospira
  • Société-mère du fabricant (2017)
    Pfizer
  • Source
    MHRA