Events

Safety Alert for ALTHIN 1000 Series Hemodialisation Machine

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
    704
  • Date
    2003-04-03
  • 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
    Make sure you received equipment repair form dated March 24, 2003. Fill in and return to Baxter. For more information contact Baxter Hospitalar Ltda, phone: 11-5694850 or your local representative. Note: The company informs that this equipment repair is only a notification. You are not asking for the equipment to be returned or removed from use. To date there are no reports of occurrences of the events described here in installed equipment.
  • Reason
    The programmed 100 system conductivity alarm limits are checked and confirmed during the machine self-test. when sodium level is changed during therapy, new conductivity alarm limits are automatically restored based on new operator programming. identified the existence of a sequence of events that may delay the reestablishment of the new conductivity alarm limits, when the sodium level is programmed to higher values ​​than previously used. this delay can only occur if the dialysate or extracorporeal alarms also occur within seven minutes of changing the sodium. if dialysis is being performed using sodium chloride-free bicarbonate concentrates (fresenius or cobe / gambro) and occurs in the sequence of events below, this may lead to metabolic acidosis. - sodium increase above 8meq / l. - extracorporeal alarms or continuous or recurrent dialysis alarms, starting seven minutes after increasing sodium levels. - stopping the bicarbonate concentrate pump before the new conductivity limits are established it is important to note that if the dialysis is being carried out using bicarbonate concentrate with sodium chloride, any to the bicarbonate pump would be detected, not being applied so the sequence of events described above.
  • Action
    Baxter will be reconfiguring by changing the BA alarm limits of the 1000 system hemodialysis machine ensuring its correct operation. These changes will prevent the undetected delivery of acid bath in the occurrence of a change in sodium level above 8 meq / L. The 1000 system operator and service manuals are being updated to reflect changes in calibration constants. The company informs you that upon receipt of the completed form you will be sending the updated section of the operation and service manual.

Device

ALTHIN 1000 Series Hemodialisation Machine

Manufacturer

BAXTER HOSPITALAR LTDA
  • Source
    ANVSANVISA