Events

Alerte Ou Avis De Sécurité sur GemStar infusion system

Selon Medicines and Healthcare products Regulatory Agency, ce/cet/cette alerte ou avis de sécurité concerne un dispositif en/au/aux/à United Kingdom qui a été fabriqué par Hospira.

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
    Safety alert / Field Safety Notice
  • Numéro de l'événement
    MDA/2013/016
  • Date
    2013-03-26
  • Date de publication de l'événement
    2014-12-17
  • Pays de l'événement
    United Kingdom
  • Source de l'événement
    MHRA
  • URL de la source de l'événement
    https://www.gov.uk//drug-device-alerts/medical-device-alert-gemstar-infusion-system-risk-of-over-infusion-low-infusion-rates-or-an-interruption-of-infusion
  • Notes / Alertes
    Data from the United Kingdom is current through April 2019. All of the data comes from the Medicines and Healthcare products Regulatory Agency, 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 recall data from the U.S. and the United Kingdom.
  • Notes supplémentaires dans les données
    The following pump faults may lead to over-infusion, low infusion rates or an interruption of infusion:occlusion detection problems, due to pressure sensor calibration drift;
    pump failure without warning, due to leaking batteries;
    voltage of lithium battery dropping below 2.4 volts, causing pump to cease functioning;
    an error with the pump’s motor assembly potentially causing the motor to rotate backwards at flow rates of less than 2 ml/hr.The MHRA continues to investigate this and other recent Field Safety Corrective Actions implemented by Hospira.
  • Cause
    (hospira) due to pump faults. (mda/2013/016).
  • Action
    Identify affected pumpsDo not use these pumps on neonates and infants aged 2 years and under.Do not use flow rates of less than 2 ml/hour.Consider using an alternative device, particularly if an an over/under infusion, or an interruption to an infusion could compromise patient safety.If an alternative is not available, follow the advice in each of the manufacturer’s Field Safety Notices.

Device

GemStar infusion system
  • Modèle / numéro de série
  • Description du dispositif
    Infusion pumps: GemStar infusion system. List numbers: 13000, 13100, 13150. The list numbers can be found on the rear of the device.
  • Manufacturer
    Hospira

Manufacturer

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