Events

Alerte De Sécurité sur Titan Stabilizers and Titan 360 Stabilizers

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.

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
    2015-01-23
  • Date de publication de l'événement
    2015-01-23
  • 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_20150123.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 cvs titan stabilizers and titan 360 stabilizers medical device manufacturer, terumo cardiovascular systems (terumo cvs) corporation has issued a field safety notice concerning its titan stabilizers and titan 360 stabilizers, with the following details: catalogue number: 1) 401-231; 2) 401-231u lot number: 1) 052r; 2) 020r, 024r, 026r, 029r, 030r, 034r, 035r, 037r, 040r, 048r dates of distribution: 1) 29 march 2013 and 24 march 2014; 2) 7 august 2013 through 17 october 2014 the manufacturer is voluntarily recalling the above lots of titan stabilizers and titan 360 stabilizers because the suction tubing clip may break when it is being attached to the stabilizing arm. although the clip is for convenience purposes and is not required for device operation, there is a potential for broken suction tubing clip fragments to fall into the surgical site. a broken suction tubing clip could delay a surgical cardiac procedure as the surgeon replaces the unit or secures the suction tubing away from the surgical site by other means. if a suction tubing clip breaks and fragments fall into a patient’s body cavity during surgery, the event could lead to a delay in the procedure as the surgeon retrieves the component. this could be complicated by the fact that the clip fragments may have sharp edges and are not radiopaque. the manufacturer has determined that the suction tubing clip material weakened during a re-sterilisation process that occurred for the affected lots listed. the manufacturer’s current sterilisation process mitigates this risk. the manufacturer advises users to stop using titan stabilizers and titan 360 stabilizers from the affected lot numbers and return all affected product to the manufacturer. according to the local supplier, the affected products are not distributed in hong kong. if you are in possession of the affected products, please contact your supplier for necessary actions. posted on 23 january 2015.

Device

Titan Stabilizers and Titan 360 Stabilizers
  • Modèle / numéro de série
  • Description du dispositif
    Medical Device Safety Alert: Terumo CVS Titan Stabilizers and Titan 360 Stabilizers
  • Manufacturer
    Terumo Cardiovascular Systems

Manufacturer

Terumo Cardiovascular Systems