Events

Alerte De Sécurité sur Venisystems Blood Bottle Pumpset with CAIR Clamp

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.

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
    2013-11-18
  • Date de publication de l'événement
    2013-11-18
  • 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_20131118a.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
    Medical device safety alert: hospira venisystems blood bottle pumpset with cair clamp it has come to our attention that medical device manufacturer, hospira, has initiated a field safety corrective action concerning venisystems blood bottle pumpset with cair clamp. the details of the affected devices are as follows: list number: a) 04643-97-01; b) 12697-65; c) 12720-65 lot number: a) 040945g, 131335g; b) 281145h, 180015h, 040115h, 880485h, 782245h, 680585h; c) 161475h, 153405h, 032595h there are increased complaints of backflow of fluid, incorrect assembly and no flow associated with the affected intravenous administration sets, which have resulted in retrograde flow. incorrect assembly of the bulb pump has the potential to prevent delivery of blood to the patient resulting in a delay of therapy. it may result in death or serious injury if a prolonged delay in the administration of life-sustaining blood products occurs. no reports of injury to patients have been received to date. the manufacturer advises users not to use and immediately quarantine the affected products, and return them to the manufacturer. hospira is improving the manufacturing process to address incorrect assembly. according to the local supplier, the affected products are not distributed in hong kong. if you are in possession of the affected product, please contact your supplier for necessary actions. posted on 18 november 2013.

Device

Venisystems Blood Bottle Pumpset with CAIR Clamp
  • Modèle / numéro de série
  • Description du dispositif
    Medical Device Safety Alert: Hospira Venisystems Blood Bottle Pumpset with CAIR Clamp
  • Manufacturer
    Hospira

Manufacturer

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