Events

Rappel de HomeChoice PRO Automated Peritoneal Dialysis (PD) System

Selon Department of Health, Therapeutic Goods Administration, ce/cet/cette rappel concerne un dispositif en/au/aux/à Australia qui a été fabriqué par Baxter Healthcare Pty Ltd.

Qu'est-ce que c'est?

Une correction ou un retrait opéré par un fabricant afin de répondre à un problème causé par un dispositif médical. Les rappels surviennent lorsqu'un dispositif médical est défectueux, lorsqu'il pourrait poser un risque pour la santé, ou les deux à la fois.

En savoir plus sur les données ici
  • Type d'événement
    Recall
  • ID de l'événement
    RC-2014-RN-00304-1
  • Classe de risque de l'événement
    Class I
  • Date de mise en oeuvre de l'événement
    2014-03-13
  • Pays de l'événement
    Australia
  • Source de l'événement
    DHTGA
  • URL de la source de l'événement
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2014-RN-00304-1
  • Notes / Alertes
    Australian data is current through July 2018. All of the data comes from the Australian Therapeutic Goods Administration, 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 recall data from the U.S. and Australia.
  • Notes supplémentaires dans les données
  • Cause
    Baxter healthcare 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 peritoneal dialysis (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.
  • Action
    The additional warning identifies symptoms related to unintended IIPV that may occur in specific patient populations and provides specific instructions to the patient and/ or caregiver to follow if IIPV is suspected. For more details, please see http://www.tga.gov.au/safety/alerts-device-automated-peritoneal-dialysis-system-140318.htm .

Device

HomeChoice PRO Automated Peritoneal Dialysis (PD) System

Manufacturer

Baxter Healthcare Pty Ltd