Events

Alerte De Sécurité sur GoPump and GOBlock Rapid Recovery System kits

Selon Department of Health, ce/cet/cette alerte de sécurité concerne un dispositif en/au/aux/à Hong Kong qui a été fabriqué par N/A.

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
    2013-05-20
  • Date de publication de l'événement
    2013-05-20
  • 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_20130520b.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.
  • Notes supplémentaires dans les données
    Medical Device Safety Alert
  • Cause
    Medical device safety alert: symbios medical products gopump and goblock rapid recovery system kits the united states food and drug administration (fda) has posted a press release issued by symbios medical products concerning their gopump and goblock rapid recovery system kits. according to the press release, the manufacturer initiated a voluntary recall of all gopump rapid recovery system kits and goblock kits manufactured with flow control components assembled prior to jul 2012. products subject to this recall were distributed between 1 apr 2011 and 30 apr 2013. these products have been found to potentially cause excessively high flow rates, which presents a risk of patient toxicity and serious injury (e.G., seizure, dysrhythmia, death) due to the rapid influx of medication particularly in patients with low body mass or advanced age. to date, there have been 5 complaints received, two of which involved serious consequences. there have been no patient deaths reported. the root cause is understood and processes have been put in place to address the issue. for details, please visit the following fda website: http://www.Fda.Gov/safety/recalls/ucm352627.Htm if you are in possession of the affected products, please contact your supplier for necessary actions. posted on 20 may 2013.

Device

GoPump and GOBlock Rapid Recovery System kits
  • Modèle / numéro de série
  • Classification du dispositif
    General Hospital and Personal Use Devices
  • Description du dispositif
    Medical Device Safety Alert: Symbios Medical Products GoPump and GOBlock Rapid Recovery System kits
  • Manufacturer
    N/A

Manufacturer

N/A
  • Source
    DH