Events

Safety Alert for HOMECHOICE FOR PERITONEAL DIALYSIS BAXTER. Anvisa Record: 10068390123. All the serial numbers.

According to Agência Nacional de Vigilância Sanitária (ANVISA), this safety alert involved a device in Brazil that was produced by Baxter Hospitalar Ltda..

What is this?

Alerts provide important information and recommendations about products. Even though an alert has been issued, it does not necessarily mean a product is considered to be unsafe. Safety Alerts, addressed to health workers and users, may include recalls. They can be written by manufacturers, but also by health officials.

Learn more about the data here
  • Type of Event
    Safety alert
  • Event ID
    1009
  • Date
    2010-03-16
  • Event Country
    Brazil
  • Event Source
    ANVISA
  • Event Source URL
    http://www.anvisa.gov.br/sistec/alerta/consultaralerta.asp
  • Notes / Alerts
    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.
  • Extra notes in the data
    The company said it is already developing changes in the instruction manual and product software to reduce the potential incidence of AVIP due to user or user misuse. For more details, see the annexes to this alert: http://portal.anvisa.gov.br/wps/wcm/connect/a5665b8041c553a39e9cdf255d42da10/Carta+ao+cliente.pdf?MOD=AJPERES and http: //portal.anvisa .gov.br / wps / wcm / connect / 3ec16a8041c554959eacdf255d42da10 / Annex + about + AVIP.pdf? MOD = AJPERES. Anvisa's Technovigilance Unit is monitoring this case.
  • Reason
    Risk of occurrence of intraperitoneal volume increase (avip), associated with the use of the homechoice cycler.
  • Action
    Clinicians should carefully schedule infusion volumes for each patient to avoid AVIP. Drainage alarms and ultrafiltration percentages should be programmed to ensure sufficient patient drainage - insufficient drainage can lead to an AVIP situation.

Device

HOMECHOICE FOR PERITONEAL DIALYSIS BAXTER. Anvisa Record: 10068390123. All the serial numbers.

Manufacturer

Baxter Hospitalar Ltda.
  • Source
    ANVSANVISA