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_20130221.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 (distal occlusion pressure sensor drift) 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 hospira, the distal pressure sensor calibration may have drifted on plum a+ infusers. if this issue happens, the following error codes maybe displayed during setup or infusion: e251, n251, e345, or e346. additionally, customers may also experience early or late distal occlusion alarms. hospira further explained that if distal pressure sensor calibration drift occurs, the pump may not sense the build-up of pressure and will not alarm when occlusion thresholds are exceeded. this full or partial occlusion may prevent fluid from reaching the patient and may result in either a delay/interruption of therapy and/or underdose, which has a worst case potential to result in significant injury or death. if this situation results in late distal occlusion alarms, excessive pressure and fluid may build up within the distal line undetected by the pressure sensor. when the distal occlusion is resolved, the built up fluid will be administrated into the patient possibly causing an overdose. overdose has the potential to result in significant injury or death. the manufacturer advises users that: they should check the technical service manual to determine if pressure drift has occurred. if the issue continues to occur and is confirmed through pvt, they should remove the device from service and contact local hospira office. 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