Alerte De Sécurité sur Primary Plumset

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
    2013-05-22
  • Date de publication de l'événement
    2013-05-22
  • Pays de l'événement
  • Source de l'événement
    DH
  • URL de la source de l'événement
  • 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 primary plumset it has come to our attention that medical device manufacturer, hospira, has initiated a field safety corrective action concerning its primary plumset. the affected list numbers are as follows: 12193 - plum a+ infusion set with 2 clave needle free ports above pump. polyethylene lined light protected set. flotation ball in drip chamber 12194 - plum a+ infusion set with 2 clave needle free ports above pump. flotation ball in drip chamber 12195 - plum a+ infusion set with 4 clave needle free ports above pump. polyethylene lined light protected set. flotation ball in drip chamber 12196 - plum a+ infusion set with 2 clave needle free ports above pump. transparent polyethylene lined set. flotation ball in drip chamber the manufacturer has received customer complaints involving the plum a+ infusion set with clave needle free ports. the plum a+ infusion set with clave needle free ports above the pump can be used for treatments that include the sequential administration of up to 4 medications plus a primary diluents (such as saline of glucose) in appropriately assessed patients. as result of sequential administration of up to 4 medications, there can be the potential for contamination of the primary diluent (saline) between the administrations of more than one drug. if the fluid level is not maintained in the sight chamber during infusion it is possible that manipulations to refloat the ball in the chamber may result in a small amount of retrograde flow of drug from the secondary (medication) line into the primary (diluent) line. there is the potential for the primary diluent to become contaminated by cytostatic drugs in a multi-therapy oncology administration. contamination of primary diluent(s) with cytostatic drugs may cause under delivery if administration of primary medication is not completed per clinical practice, or particulate matter resulting from mixing of incompatible medications. the manufacturer advises users to follow instructions mentioned in the field safety notice, when priming and flushing with more than one secondary medication, and when delivery of sequential medications per healthcare provider policy. furthermore, hospira is updating the patient information leaflet and training literature, and will be providing a training implementation plan to all applicable healthcare professionals. if you are in possession of the affected product, please contact your supplier for necessary actions. posted on 22 may 2013.

Device

  • Modèle / numéro de série
  • Description du dispositif
    Medical Device Safety Alert: Hospira Primary Plumset
  • Manufacturer

Manufacturer

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