Events

Alerte De Sécurité sur Peritoneal Dialysis Transfer 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 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
    2013-03-05
  • Date de publication de l'événement
    2013-03-05
  • 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_20130305.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 peritoneal dialysis transfer set medical device manufacturer,baxter healthcare ltd., has issued a letter to customers concerning capd solution transfer set with locking connector(product code 5c4160)and minicap extended life pd transfer set with twist clamp (product code 5c4482). baxter would like to provide an important information regarding changes that are being made to instructions for use(ifu) for baxter peritoneal dialysis transfer set with the above product codes to improve product labeling and ensure consistency of information across the baxter transfer set product family.Key additions to the ifu include: the set is to be used with the baxter locking titanium adapter for peritoneal dialysis catheter in disconnect applications and in cycler applications where aseptic connections and disconnections are performed at the transfer set/cycler set juncture. wipe for a minimum of 1 minute around the connection between the titanium adapter and the transfer set or locking cap with a sterile gauze pad soaked in povidone-iodine. it is recommended that thyroid function be monitored in patients with small peritoneal dialysate fill volumes, typically infants and children. reuse or reprocessing of a single use device may lead to contamination and compromised device function or structural integrity. do not use if tip protectors are not in place. this product does not contain natural rubber latex. baxter advises customers to communicate to the patient forapplicable changes to the ifu and emphasize the importance of following the ifu at each pd transfer set installation or exchange. according to the local supplier, the affected products were distributed in hong kong. if you are in possession of the affected product, please contact your supplier for necessary actions. posted on 5 march 2013.

Device

Peritoneal Dialysis Transfer Set
  • Modèle / numéro de série
  • Description du dispositif
    Medical Device Safety Alert: Baxter Peritoneal Dialysis Transfer Set
  • Manufacturer
    Baxter Healthcare Ltd.

Manufacturer

Baxter Healthcare Ltd.