Events

Alerte De Sécurité sur HomeChoice Automated Peritoneal Dialysis System

Selon Agência Nacional de Vigilância Sanitária (ANVISA), ce/cet/cette alerte de sécurité concerne un dispositif en/au/aux/à Brazil qui a été fabriqué par Baxter Hospitalar Ltda.

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
  • ID de l'événement
    801
  • Date
    2005-12-03
  • Pays de l'événement
    Brazil
  • Source de l'événement
    ANVISA
  • URL de la source de l'événement
    http://www.anvisa.gov.br/sistec/alerta/consultaralerta.asp
  • Notes / Alertes
    Brazilian data is current through June 2018. All of the data comes from Anvisa, 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 Brazil.
  • Notes supplémentaires dans les données
    Although the possibility of this type of event occurring is remote, it presents potential risk due to the shock. If you find it difficult to turn the machine on or off, or if you notice that the power switch is loose, immediately unplug the machine and contact the technical service by calling 0800-125522 option 3 for orientation. According to Company information, no similar occurrence was reported by its customers in Brazil. The UTVIG / ANVISA - Tecnovigilância Unit will be following the entire process of updating the HomeChoice machines until the moment of its closure.
  • Cause
    Reports from patients who received electric shock using homechoice. investigation conducted through the company baxter healthcare corporation, route 120 & wilson road, round lake, 60073-0490, confirmed that the homechoice machine's on / off switch pin loosened, causing a circuit breaker. this key is not grounded.
  • Action
    All HomeChoice machines are being upgraded with on-off switches. All new and refurbished machines, manufactured after August 1, 2004, have a grounded on / off switch.

Device

HomeChoice Automated Peritoneal Dialysis System

Manufacturer

Baxter Hospitalar Ltda
  • Source
    ANVSANVISA