Events

Alerte De Sécurité sur Spectra Optia Apheresis 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 Terumo BCT.

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
    2013-08-23
  • Date de publication de l'événement
    2013-08-23
  • 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_20130823.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: terumo bct spectra optia apheresis system medical device manufacturer, terumo bct, inc., has issued a field safety notice concerning spectra optia apheresis system. terumo bct has modified the spectra optia system’s standard filler in order to reduce the incidence of leaks in the channel of the tubing set during mononuclear cell (mnc) collection procedures. leaks in the channel of the tubing set have many different causes. the manufacturer has identified a very specific type of channel leak caused by a pinhole-sized tear in the soft vinyl wall near the set’s hard plastic connector. this type of leak has occurred primarily during long mnc collection procedures and results in a minor blood spill that remains fully contained within the system’s centrifuge chamber. although the reported incidence of this type of channel leak is quite low (< 0.23% in spectra optia collection sets manufactured since july, 2010) and no serious adverse events have been reported, even a small tubing set leak can result in the premature termination of an apheresis procedure. consequently, terumo bct has modified and strengthened the system’s standard filler to better support the tubing set during centrifugation. according to the manufacturer, to help identify the modified filler, “spectra optia” is engraved on the top side of the filler. terumo bct will provide one modified standard filler for each device to all customers who use the system to perform mnc collection procedures. the manufacturer will begin installing the modified filler over a 12-month period, with the installation likely occurring during a scheduled preventive maintenance visit. the machine’s original filler will be removed from facility for recycling/disposal. according to the local supplier, the affected products were distributed in hong kong. if you are in possession of the products, please contact your supplier for necessary actions. posted on 23 august 2013.

Device

Spectra Optia Apheresis System
  • Modèle / numéro de série
  • Description du dispositif
    Medical Device Safety Alert: Terumo BCT Spectra Optia Apheresis Systems
  • Manufacturer
    Terumo BCT

Manufacturer

Terumo BCT