Events

Alerte De Sécurité sur GemStar™ Bolus Cord used with Gemstar™ Pump

Selon Department of Health, ce/cet/cette alerte de sécurité concerne un dispositif en/au/aux/à Hong Kong qui a été fabriqué par Hospira Inc.

Qu'est-ce que c'est?

Les alertes fournissent des informations importantes et des recommandations concernant les dispositifs médicaux. Le fait qu'une alerte soit émise ne signifie pas nécessairement qu'un dispositif soit dangereux. Les alertes de sécurité, qui sont envoyées tant aux travailleurs du secteur médical qu'aux utilisateurs de ces dispositifs, peuvent inclure des rappels. Elles peuvent être rédigées par des fabricants mais aussi par des autorités en charge de la santé.

En savoir plus sur les données ici
  • Type d'événement
    Safety alert
  • Date
    2012-03-22
  • Pays de l'événement
    Hong Kong
  • Source de l'événement
    DH
  • URL de la source de l'événement
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20120322d.html
  • Notes / Alertes
    Hong Kong data is current through September 2018. All of the data comes from the Department of Health (Hong Kong), 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 Hong Kong.
    ICU Medical, Inc. acquired from Pfizer in early 2017, Hospira Infusion Systems, the portion of Hospira dedicated to develop infusion pumps.
  • Notes supplémentaires dans les données
    Medical Device Safety Alert
  • Cause
    Field safety notice: hospira gemstar™ bolus cord used with gemstar™ pump it has come to our attention that the health canada was aware of problems associated with the gemstar™ bolus cord, used with the gemstar™ pump manufactured by hospira inc. post-market incident reports indicate that defects with these cords can lead to failure to deliver, intermittent operation, and unrequested bolus delivery. the gemstar™ pump has software controls that set a maximum allowable dosage and minimum lockout time. an audible chirp signals for every requested delivery and provides notification to the patient and attendant staff. these safety provisions help to mitigate the potential risk to the patient. the health canada has not received any reports of patient injury. the manufacturer's preliminary investigation suggests that the cord may be damaged by the force applied to remove the cord from the base of the gemstar™ unit. this may lead to cracking and open circuits or short circuits. if you are in possession of the product, please contact your supplier for necessary actions.

Device

GemStar™ Bolus Cord used with Gemstar™ Pump
  • Modèle / numéro de série
  • Description du dispositif
    Medical Device Safety Alert: Hospira GemStar™ Bolus Cord used with Gemstar™ Pump
  • Manufacturer
    Hospira Inc

Manufacturer

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