Events

Alerte De Sécurité sur MiniCap Extended Life Peritoneal Dialysis Transfer Set with Twist Clamp

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 Ltd.

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
    2014-05-15
  • Date de publication de l'événement
    2014-05-15
  • 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_20140515.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 minicap extended life peritoneal dialysis transfer set with twist clamp the australia therapeutic goods administration (tga) posted a medical device safety alert concerning minicap extended life peritoneal dialysis (pd) transfer set with twist clamp manufactured by baxter healthcare ltd. the affected product code is r5c4482 and only lot number h12f18054 is affected. the manufacturer has received complaints reporting connection issues between the pd transfer set catheter connector and an adapter with this lot number. connection issues between the pd transfer set catheter connector and an adapter may lead to leaks and contamination of the fluid pathway which may result in peritonitis. the manufacturer advises hospitals and distributors to locate and return all the affected products at their facility. health professionals are asked to ensure that home patients are notified of this recall and identify patients who are currently using the affected lot for replacing the unused transfer sets with unaffected stock. for details, please refer to tga websites: http://www.Tga.Gov.Au/sara/arn-detail.Aspx?k=rc-2014-rn-00536-2 and http://www.Tga.Gov.Au/safety/alerts-device-minicap-extended-life-pd-140515.Htm according to the local supplier, the affected products were not distributed in hong kong. if you are in possession of the affected products, please contact your supplier for necessary actions. posted on 15 may 2014.

Device

MiniCap Extended Life Peritoneal Dialysis Transfer Set with Twist Clamp
  • Modèle / numéro de série
  • Description du dispositif
    Medical Device Safety Alert: Baxter MiniCap Extended Life Peritoneal Dialysis Transfer Set with Twist Clamp
  • Manufacturer
    Baxter Healthcare Ltd

Manufacturer

Baxter Healthcare Ltd