Events

Alerte De Sécurité sur HomeChoice PRO Automated Peritoneal Dialysis (PD) System

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
    2014-03-19
  • Date de publication de l'événement
    2014-03-19
  • 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_20140319.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 homechoice pro automated peritoneal dialysis (pd) system the australia therapeutic goods administration (tga) posted a medical device safety alert concerning homechoice pro automated peritoneal dialysis (pd) system with product code r5c8320, manufactured by baxter healthcare. the manufacturer is implementing additional warning in homechoice/homechoice pro device product labelling related to patients more vulnerable to unintended increased intraperitoneal volume (iipv), also known as overfill. specific populations using pd therapy including neonates, infants, small children and any patient with significant heart or lung disease are more vulnerable to the negative effects of excessive retention of fluid in the peritoneal cavity that may be related to their dialysis therapy. overfilling with dialysate (iipv) or not draining enough fluid during pd therapy can result in excess fluid in the abdomen accompanied by patient symptoms. the manufacturer has contacted the suppliers (primarily hospitals) of homechoice pro automated peritoneal dialysis units to provide further information about the recall for product correction and instructions to contact affected patients. the manufacturer also advises customers that if unintended increased intraperitoneal volume (overfill) is suspected, they should immediately initiate a manual drain and contact their treating health professional. for details, please refer to tga websites:http://www.Tga.Gov.Au/sara/arn-detail.Aspx?k=rc-2014-rn-00304-1 and http://www.Tga.Gov.Au/safety/alerts-device-automated-peritoneal-dialysis-system-140318.Htm if you are in possession of the affected products, please contact your supplier for necessary actions. posted on 19 march 2014.

Device

HomeChoice PRO Automated Peritoneal Dialysis (PD) System
  • Modèle / numéro de série
  • Description du dispositif
    Medical Device Safety Alert: Baxter HomeChoice PRO Automated Peritoneal Dialysis (PD) System
  • Manufacturer
    Baxter Healthcare

Manufacturer

Baxter Healthcare