Events

Alerte De Sécurité sur Prismaflex Control Unit

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

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
    2018-05-07
  • Date de publication de l'événement
    2018-05-07
  • 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_20180507b.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: baxter healthcare prismaflex control unit medical device manufacturer, baxter healthcare, has issued a medical device safety alert concerning its prismaflex control unit, details product models and serial numbers as below: product: 1) prismaflex 4.11; 2) prismaflex 5.00 row; 3) prismaflex 6.10 row; 4) prismaflex 7.11; 5) prismaflex 7.Xx row; 6) prismaflex system serial number: all the manufacturer will be installing new firmware on all prismaflex control units to address for the units to exhibit a failure mode with the pump module electronics. the failure mode may result in a “voltage out of range” malfunction alarm, which causes the device to enter a “safe state” and become inoperable until it is serviced. according to the manufacturer, the “voltage out of range” malfunction alarm causes the prismaflex control unit to enter a “safe state” by stopping all pumps and closing the return line clamp. this failure mode can occur at any time during use and may result in an interruption and/or delay in therapy. patient harm is not expected as the blood may be manually return to the patient. according to the local supplier, there were no associated adverse events, patient injury and product complaints reported in hong kong. the manufacturer advises that operators may continue to safely use prismaflex control units that have not exhibited the “voltage out of range” malfunction alarm. the manufacturer will be releasing new firmware that will prevent the malfunction from occurring. according to the local supplier, the affected products are distributed in hong kong. if you are in possession of the products, please contact your supplier for necessary actions. posted on 7 may 2018.

Device

Prismaflex Control Unit
  • Modèle / numéro de série
  • Description du dispositif
    Medical Device Safety Alert: Baxter Healthcare Prismaflex Control Unit
  • Manufacturer
    Baxter Healthcare

Manufacturer

Baxter Healthcare