Events

Alerte De Sécurité sur COBE Spectra Bone Marrow Processing Set

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 Inc..

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
    2013-10-16
  • Date de publication de l'événement
    2013-10-16
  • 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_20131016f.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 cobe spectra bone marrow processing set medical device manufacturer, terumo bct inc., has issued a field safety notice concerning cobe spectra bone marrow processing tubing set. the affected catalogue number is 70630, and the affected lot numbers are 10t15261, 10t15296, 12t15257, 05u15258 and 09u15271. the lot numbers 10t15261 and 10t15296 have an expiration date of 1 oct 2013. a leak at the tubing bond to the y-connector in the bone marrow processing (bmp) set can, with very low probability, resulting in bacterial contamination of a transfusion product. terumo bct is aware of four reported events related to a leak at the tubing bond to the y-connector in the bmp set that did not result in adverse event and does not consider this failure mode a systemic issue. if the contaminated product is not tested prior to transfusion, patients may experience serious infections and other related serious adverse events. the manufacturer advises users not to use the affected products. it has implemented corrective actions to improve the manufacturing process for bonding the y-connector to the tubing. for example, 100% inspection was added to the manufacturing operating procedure to verify bonding specifications for the bond to the bone marrow bag. 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 16 october 2013.

Device

COBE Spectra Bone Marrow Processing Set
  • Modèle / numéro de série
  • Description du dispositif
    Medical Device Safety Alert: Terumo COBE Spectra Bone Marrow Processing Set
  • Manufacturer
    Terumo BCT Inc.

Manufacturer

Terumo BCT Inc.