Events

Alerte De Sécurité sur Plum A+ Family of Infusers

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
    2013-02-21
  • Date de publication de l'événement
    2013-02-21
  • 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_20130221a.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 plum a+ family of infusers (fluid shield- fluid ingress) the medicines and healthcare products regulatory agency (mhra), united kingdom posted a medical device safety alert concerning plum a+ family of infusers manufactured by hospira uk limited. the affected list numbers are: 11005 (plum a+ hyperbaric infusion system) 11971, 12391 (plum a+ single channel infusion system) 12348, 12618 (plum a+3 infusion pump system) 20678 (plum a+3 infusion pump with hospira mednet software) 20792 (plum a+ infusion pump with hospira mednet software) according to the manufacturer, there is a potential for fluid ingress into the plum a+ mechanism assembly. this issue may result in the device being unable to recognize installed tubing or installed cassettes, or cause valve cassette test failures. subsequently, audible and visual alarms may be triggered and lead to a delay or interruption in therapy. hospira explained that the severity of the problem is dependent upon the underlying condition of the patient and the treatment being prescribed. significant injury or death can be resulted. hospira has identified multiple root causes for this issue, including spillage/ contamination on the pressure sensing system from iv and cleaning fluids, design robustness of the fluid shield and fluid contamination/ build-up leading to misalignment of the pressure sensor pins with the cassette disphragm. while hospira is carrying out remediation activities to address the problem, customers are reminded to clean the infuser weekly according to the plum a+ system operations manual. for details, please visit the following mhra website: http://www.Mhra.Gov.Uk/safetyinformation/safetywarningsalertsandrecalls/ fieldsafetynotices/con234577 if you are in possession of the affected products, please contact your supplier for necessary actions. posted on 21 february 2013.

Device

Plum A+ Family of Infusers
  • Modèle / numéro de série
  • Description du dispositif
    Medical Device Safety Alert: Hospira Plum A+ Family of Infusers
  • Manufacturer
    Hospira

Manufacturer

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