Events

Alerte De Sécurité sur UniCel DxC Synchron Systems No Foam Reagent

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

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
    2016-07-07
  • Date de publication de l'événement
    2016-07-07
  • 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_20160707a.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: beckman coulter unicel dxc synchron systems no foam reagent medical device manufacturer, beckman coulter, has issued a medical device safety alert concerning its unicel dxc synchron systems no foam reagent [reference number: b64130]. dxc no foam reagent is intended to prevent formation of foam and/or bubbles in the dxc waste system of the hydropneumatic subsystems. the manufacturer has identified an incompatibility between no foam dxc reagent (b64130) and the dxc hydropneumatic parts associated with no foam delivery. over time, this incompatibility may lead to: breaks in no foam cap assembly (pn a84827) cracks in no foam waste collector (pn a60007/a64665) seepage outside no foam tubing (pn’s a10027, a10028 and a67123) according to the manufacturer, this incompatibility does not affect no foam’s ability to perform its function and there is no impact to patient results. cracks in the waste collector may stop instrument operation due to vacuum error, and potentially lead to biohazardous waste exposure. also, cracks in the no foam cap and seepage from the no foam tubing may lead to exposure to no foam. the manufacturer is replacing no foam dxc reagent (ref b64130) with ref 469110, a previous unicel dxc systems no foam formulation. a hardware modification to replace impacted hardware and no foam tubing will be scheduled after completion of the switch over to the replacement no foam ref 469110. users can continue to use no foam dxc ref b64130 until replacement is received and they will be contacted for system modification scheduling. according to the local supplier, the affected products are distributed in hong kong. if you are in possession of the affected products, please contact your supplier for necessary actions. posted on 7 july 2016.

Device

UniCel DxC Synchron Systems No Foam Reagent
  • Modèle / numéro de série
  • Description du dispositif
    Medical Device Safety Alert: Beckman Coulter UniCel DxC Synchron Systems No Foam Reagent
  • Manufacturer
    Beckman Coulter

Manufacturer

Beckman Coulter