Events

Alerte De Sécurité sur MARS Kit Gambro, Type 1116/1-X-MARS

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
    2018-01-03
  • Date de publication de l'événement
    2018-01-03
  • 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_20180103a.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 mars kit gambro, type 1116/1-x-mars medical device manufacturer, baxter healthcare, has issued a medical device safety alert concerning its mars kit gambro, type 1116/1-x-mars [product code: 800540; lot numbers (expiration date): 22651 (01 september 2019), 22708 (30 september 2019)]. the manufacturer has received customer complaints regarding leakage in the albumin circuit. the leakage was caused by an inadequate adhesive connection of the tubing to the hansen connector of the mars tube set which is part of the mars treatment kit. according to the manufacturer, an undetected leaking albumin circuit could lead to excessive fluid removal from the patient during albumin dialysis. this could lead to hypovolemia. delay or interruption of therapy may also occur if the issue is detected during priming. the manufacturer has not received any reports of adverse events or patient injury associated with this issue. affected users are advised to locate and remove all affected product from facility. product recall is on-going. according to the local supplier, the affected products are distributed in hong kong. if you are in possession of the affected products, please contact your supplier for necessary actions. posted on 03 january 2018.

Device

MARS Kit Gambro, Type 1116/1-X-MARS
  • Modèle / numéro de série
  • Description du dispositif
    Medical Device Safety Alert: Baxter Healthcare MARS Kit Gambro, Type 1116/1-X-MARS
  • Manufacturer
    Baxter Healthcare

Manufacturer

Baxter Healthcare