Events

Alerte De Sécurité sur TD-Synergy Blood Bank module connected to TD-Synergy (known as LIS connection)

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

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
    2013-04-19
  • Date de publication de l'événement
    2013-04-19
  • 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_20130419.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: technidata td-synergy blood bank module connected to td-synergy (known as lis connection) medical device manufacturer, technidata sas, has issued a field safety notice concerning a defect affecting all versions of the td-synergy blood bank module connected to td-synergy (known as lis connection). the blood bank module retains one of the two blood group determinations whereas it should not retain any and should alert the users. this issue identified at the montfort site (canada) occurs when the two blood group determinations are received in the same astm message. the td-synergy blood bank module version is v04.71.B, but this defect could potentially occur in all versions. the identified scenario is the following: for a patient with no known blood group on the blood bank module, when an astm message is received from td-synergy including two different blood group determinations, the blood bank module retains one of the determinations as the blood group for this patient whereas it should not retain any and should alert the users. this defect can occur if the following conditions are met: blood bank module connected to td-synergy (lis connection) unknown blood group on the blood bank module two different blood group determinations for the same sample in the first transmission of the astm file blood bank module is set with extended compatibility (see general settings parameter) specific dongle option « double determination on a single sample » the severity is considered very high as the defect could lead to an incorrect transfusion. the probability is assessed as low given the number of conditions to meet. the manufacturer advises users to find correction packages corresponding to the td-synergy blood bank module on the technidata website and contact their support team if the corresponding correction package is not available on the website. according to the manufacturer, the affected products were distributed in hong kong. if you are in possession of the affected products, please contact your supplier for necessary actions. posted on 19 april 2013.

Device

TD-Synergy Blood Bank module connected to TD-Synergy (known as LIS connection)
  • Modèle / numéro de série
  • Description du dispositif
    Medical Device Safety Alert: TECHNIDATA TD-Synergy Blood Bank module connected to TD-Synergy (known as LIS connection)
  • Manufacturer
    TECHNIDATA SAS

Manufacturer

TECHNIDATA SAS