Events

Alerte De Sécurité sur Advanced Perfusion System 1

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 Cardiovascular Systems Corporation.

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
    2012-09-14
  • Date de publication de l'événement
    2012-09-14
  • 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_20120914.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: silicone tracheostomy tubes medical device manufacturer, terumo cardiovascular systems (cvs) has issued a field safety corrective action regarding the recall of flow module for terumo advanced perfusion system 1 [catalogue no.: 802018; serial number range: 00032, 00042, 00056, 00147, 00623, 00700-00764, 00766-00820, 00823-00847. the manufacturer received two reports of random flow readings and/or intermittent false back flow alarms for the terumo advanced perfusion system 1 when there was no tubing in the flow sensor. when operating as intended, the module will generate '---' (three dashes) in the display, and issue a ‘check sensor’ alert message, when there is no tubing in the flow sensor. the manufacturer’s investigation found that: the malfunction was caused by an improperly set voltage level in a population of circuit boards used in the flow modules for terumo system 1. the module operates correctly if tubing is installed. this failure of the flow module is expected to occur very rarely in the affected population and is easily detectable. besides, the failure only occurs when there is no tubing installed in the flow sensor and therefore the only risk to the patient is if the failure results in operator confusion, distraction or a delay of surgical procedure. there are no known reports of patient injury as a result of this issue. the manufacturer has decided to replace all flow modules in the affected population. users can continue to use their flow modules while awaiting replacement. according to the local supplier, the affected products were not distributed in hong kong. if you are in possession of the affected product, please contact your supplier for necessary actions. posted on 14 september 2012.

Device

Advanced Perfusion System 1

Manufacturer

Terumo Cardiovascular Systems Corporation