Events

Alerte De Sécurité sur Myocardial Protection System Delivery Sets

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

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
    2015-10-30
  • Date de publication de l'événement
    2015-10-30
  • 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_20151030b.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: quest medical myocardial protection system delivery sets the united states food and drug administration (fda) has issued an alert concerning myocardial protection system (mps) delivery sets, manufacturer by quest medical incorporation. the products have been found to intermittently exhibit a seal failure during use, which potentially could result in patient blood loss. the affected devices are shown below: a) mps delivery set w/arrest agent and additive cassettes, heat exchanger & 10 ft. delivery tubing model number: 5001102 lot number: 0491795e04, 0492175e04, 0492185e06, 0492195e06, 0492615e06, 0492625e08, 0492635e08, 0489905y04, 0490245y06, 0493075u02, 0493085u02, 0493435u04 0493675u04, 0493685u07, 0494465u07, 0494475u09, 0494855g01, 0495215u11 0495225u11, 0495505g02, 0495515g02, 0496535g08, 0496875g08, 0496885g08, 0497245s02 b) mps delivery set with 6 ft. delivery tubing model number: 5001102-as lot number: 0492205e03, 0493695u04, 0494485u07, 0495525g02, 0497265s02 c) mps low volume delivery set model number: 7001102 lot number: 0492765e07 the manufacturer has received twenty complaints alleging this seal failure which have resulted in 16 instances of patient blood loss during surgery. nonetheless, there have been no reports of patient injuries as a result of the alleged issue to date. the manufacturer recommends that consumers should cease to use the affected lots of the mps delivery sets while product recall is on-going if you are in possession of the affected products, please contact your supplier for necessary actions. for details, please refer to the fda websites:http://www.Fda.Gov/safety/medwatch/safetyinformation/safetyalertsforhumanmedicalproducts/ucm470194.Htmhttp://www.Fda.Gov/safety/recalls/ucm470146.Htm posted on 30 october 2015.

Device

Myocardial Protection System Delivery Sets
  • Modèle / numéro de série
  • Description du dispositif
    Medical Device Safety Alert: Quest Medical Myocardial Protection System Delivery Sets
  • Manufacturer
    Quest Medical

Manufacturer

Quest Medical