Events

Safety Alert for HOMECHOICE FOR PERITONEAL DIALYSIS BAXTER .. REG. ANVISA: 10068390123.

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
    899
  • Date
    2008-01-24
  • 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
    Attached to the communication letter to be sent by Baxter Ltda to its customers, will follow a response form that must be completed as soon as possible and sent to the company. ### The company announces the closure of the field action of updating the software of the machines through the file 824688 / 09-2, 10/29/2009.
  • Reason
    During a filling cycle, if the system is shut down or power failure occurs, the homechoice system may not register up to the last four pump drives infused into the patient when the power is reestablished. such a situation may lead to unregistered application of 15 to 60 ml of the fluid being infused into the patient.
  • Action
    The company Baxter Hospitalar Ltda will be providing an updated version of the equipment software and has already begun to contact its customers through communication letters. The Technovigilance Unit is following the case.

Device

HOMECHOICE FOR PERITONEAL DIALYSIS BAXTER .. REG. ANVISA: 10068390123.

Manufacturer

BAXTER HOSPITALAR LTDA
  • Source
    ANVSANVISA