Events

Avis De Sécurité sur ALL HOSPIRA GEMSTAR FAMILY OF INFUSERS

Selon Health Products Regulatory Authority, ce/cet/cette avis de sécurité concerne un dispositif en/au/aux/à Ireland qui a été fabriqué par Hospira Inc..

Qu'est-ce que c'est?

Les avis de sécurité sont des communications que les fabricants de dispositifs médicaux ou leurs représentants font parvenir en particulier aux travailleurs du secteur médical, mais aussi aux utilisateurs de ces dispositifs. Les avis de sécurité concernent les actions entreprises quant aux dispositifs présents sur le marché et peuvent inclure des rappels et des alertes.

En savoir plus sur les données ici
  • Type d'événement
    Field Safety Notice
  • Numéro de l'événement
    SN2013(03)
  • Date
    2013-03-27
  • Pays de l'événement
    Ireland
  • Source de l'événement
    HPRA
  • URL de la source de l'événement
    http://www.hpra.ie/homepage/medical-devices/safety-information/safety-notices/item?t=/all-hospira-gemstar-family-of-infusers&id=087cf825-9782-6eee-9b55-ff00008c97d0
  • Notes / Alertes
    Irish data is current through April 2019. All of the data comes from the Health Products Regulatory Authority (Ireland), 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 Ireland.
    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
  • Cause
    Hospira has circulated six (6) field safety notices (fsns), since august 2011, advising of various issues relating to the gemstar family of infusers which could result in overdose, under-dose or a delay/interruption in therapy.
  • Action
    1. Ensure that the appropriate personnel are made aware of this notice and the attached Caution in Use FSN.  2. Identify affected pumps.  3. Hospira has implemented the following Restriction for Use into clinical practice for the GemStar Infusion Pumps:  - Do not use on all neonatal populations and infants up to two (2) years of age.  - Do not use on any patients where therapy is delivered at flow rates 2.0ml/hr or less.  4. The manufacturer and the IMB advise users to weigh the risk/benefit to patients associated with the use of these devices when administering critical therapies.  5. Customers should consider the use of an alternative pump, particularly in patients in which an overdose, under-dose or delay/interruption in therapy could compromise patient safety.  6. Follow the manufacturer’s recommendations in the attached Caution in Use FSN.

Device

ALL HOSPIRA GEMSTAR FAMILY OF INFUSERS
  • Modèle / numéro de série
  • Description du dispositif
    ALL HOSPIRA GEMSTAR FAMILY OF INFUSERS
  • Manufacturer
    Hospira Inc.

Manufacturer

Hospira Inc.
  • Société-mère du fabricant (2017)
    Pfizer
  • Source
    HPRA