Events

Alerte De Sécurité sur CELLTRACKS AUTOPREP System

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

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
    2014-01-22
  • Date de publication de l'événement
    2014-01-22
  • 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_20140122b.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: cell search celltracks autoprep system medical device manufacturer, cell search, has issued a field safety notice concerning celltracks autoprep system (product code: 9541 and 9541r). the manufacturer has received reports of an increase in error codes related to the peristaltic pump tubing when using the celltracks autoprep system. there were also reports that the wash bowls overflowed after changing the peristaltic pump tubing following the monthly maintenance procedure. the monthly maintenance kit with part number ct9554 contains packages of peristaltic pump tubing and fluid bottle filters. peristaltic pump tubing may be ordered separately using the peristaltic pump tubing kit with part number ct4274. according to the manufacturer, monthly maintenance kits dated 20 jan 2014 or later will contain acceptable tubing. the manufacturer’s investigation determined there was a difference in the rigidity in some of the peristaltic pump tubing. tubing that is more rigid does not allow for proper fluid transfer and may result in flooding or peristaltic pump tubing fluid related errors. the manufacturer advises users of the followings: call local representatives to arrange replacement of the remaining monthly maintenance kit(s) (part no. ct9554). it is acceptable to continue to use the existing inventory of peristaltic pump tubing until replacement order arrives. discard the remaining inventory of monthly maintenance kit(s) and peristaltic pump tubing upon receipt of replacement order. according to the local supplier, the affected products were not distributed in hong kong. if you are in possession of the products, please contact your supplier for necessary actions. posted on 22 january 2014.

Device

CELLTRACKS AUTOPREP System
  • Modèle / numéro de série
  • Description du dispositif
    Medical Device Safety Alert: Cell Search CELLTRACKS AUTOPREP System
  • Manufacturer
    Cell Search

Manufacturer

Cell Search