Events

Alerte De Sécurité sur Q core’s Sapphire Infusion Pumps

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
    2016-05-24
  • Date de publication de l'événement
    2016-05-24
  • 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_20160524b.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 q core’s sapphire infusion pumps medical device manufacturer, hospira, has issued a medical device safety alert concerning q core’s sapphire infusion pumps (hospira list number: 163113601). the manufacturer’s investigation and analysis has determined that with specific drug concentrations of iron sucrose (range of 0.7 to 2.8mg/ml, “concentration range”) the pump may misinterpret the iron sucrose solution as air rather than an opaque solution, resulting in the generation of a false air-in-line alarm. risk to health is limited to a delay in the administration of iron sucrose infusion in the concentration range only. the issue, if occurs, is immediately apparent to the provider at the beginning of the treatment as an air-in-line alarm is generated, which does not allow the treatment to start. in addition, iron sucrose therapy is not used for acute treatment of anaemia, the effected of iron sucrose takes days to occur, and alternative delivery mechanism are readily available. thus the risks of delay in therapy of intravenous iron sucrose are remote. according to the manufacturer, intensive research has not revealed any other medication which raises the same issue, i.E., this issue is unique for iron sucrose and no other drug. the software algorithms within the pump are being improved to restore the device to its original specifications, enabling consistent delivery of the aforementioned concentration of iron sucrose. this improvement will address the root cause and prevent the false alarms. according to the local supplier, the affected products are distributed in hong kong. if you are in possession of the affected products, please contact your supplier for necessary actions. posted on 24 may 2016.

Device

Q core’s Sapphire Infusion Pumps
  • Modèle / numéro de série
  • Description du dispositif
    Medical Device Safety Alert: Hospira Q core’s Sapphire Infusion Pumps
  • Manufacturer
    Hospira

Manufacturer

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