Events

translation missing: fr.activerecord.attributes.event.titles.recall_field_safety_notice

Selon Saudi Food & Drug Authority, ce/cet/cette translation missing: fr.activerecord.attributes.event.types.recall_field_safety_notice concerne un dispositif en/au/aux/à Saudi Arabia qui a été fabriqué par Hospira Inc.

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
    Recall / Field Safety Notice
  • ID de l'événement
    mdprc 101 03 12 000
  • Date de mise en oeuvre de l'événement
    2012-03-25
  • Pays de l'événement
    Saudi Arabia
  • Source de l'événement
    SFDA
  • URL de la source de l'événement
    https://ncmdr.sfda.gov.sa/Secure/CA/CaViewRecall.aspx?caid=5&rid=1619
  • Notes / Alertes
    Saudi data is current through January 2019. All of the data comes from the Saudi Food & Drug Authority, 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 Saudi Arabia.
  • Notes supplémentaires dans les données
    Report Source: NCAR
    SFDA urges all hospitals that have devices subjected to recall, to contact the company.
  • Cause
    Hospira, inc. has received customer reports of bolus delivery failures when using the gemstar bolus cord. possible failures may be a result of cracked or damaged bolus cords which may result in an open or short circuit of the bolus cord. potential risk due to failure of the bolus cord is the potential for an unrequested bolus delivery or the failure to deliver requested medication to the patient. the amount of unrequested delivery will be limited by programming lockout volumes. an unrequested narcotic delivery may cause over sedation requiring possible medical intervention, but is unlikely to result in serious or life threatening injuries. the failure to deliver requested narcotic medication may result in the lack of adequate pain relief.

Device

Infusion pump, GemStar Bolus Cord
  • Modèle / numéro de série
    List Number 13027 Serial no.: All Lot/batch no.: All
  • Description du dispositif
    Infusion pump, Bolus Cord, delivery
  • Manufacturer
    Hospira Inc

Manufacturer

Hospira Inc
  • Société-mère du fabricant (2017)
    Pfizer
  • Représentant du fabricant
    AL-KAMAL Import, Riyadh, (01) 2181122
  • Source
    SFDA