Events

Safety Alert for Hemodialysis machine, model SPS-550. Hemodialysis machine, model SPS-1550.

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
    720
  • Date
    2003-03-25
  • 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
    COMMERCIAL NAME: SPS-550 HEMODIALISING MACHINE - REGISTER NUMBER: 10068390085 - COMMERCIAL NAME: SPS-1550 HEMODIALISING MACHINE - REGISTER NUMBER: 10068390088 - Please note that this notice is only a notice. BAXTER is not asking you to return the equipment or remove it from use. If you need more information, please contact BAXTER at 0800 125522 - option 1.
  • Reason
    Baxter hospitalar ltda hereby provides important operating instructions for sps 550 and sps 1550 single patient system (sps) hemodialysis machines at times where manual control of ultrafiltration is required by the adjustment of transmembrane pressure (tmp) . this communication aims to reduce the possibility of excessive or deficient ultrafiltration when manually controlled. manual control of ultrafiltration with sps 550 and sps 1550 can be used in the event of a fault in the automatic ultrafiltration control system. the ultrafiltration controller will indicate the failure of the system by displaying an error code on the front panel. error codes are preceded by the letters "fl" followed by a number that specifies the fault (eg fl-01, fl-02, fl-04, fl-05, fl., -06, fl-07, and fl -08). the current operating instructions for sps 550 and sps 1550 indicate that the ultrafiltration controller can be switched off at the occurrence of one of the error codes above, thus passing the ultrafiltration control to be performed manually by adjusting the transmembrane pressure (tmp) if the dialyzer in use is not high flow or the ultrafiltration rate does not exceed 8.0 ml / h / mmhg. baxter has discovered that by turning off the ultrafiltration controller in three of these specific error codes, the safe execution of manual ultrafiltration can be changed. in this way we are changing the current procedures in order to recommend that the treatment be interrupted if one of the following error codes is displayed: - fl 04 - indicates a defect of the isolation / bypass valves. these valves are the primary protection system for all dialysate alarms and some blood alarms. -fl 07 - indicates an uncorrected alarm. an uncorrected alarm indicates the possibility of a failure in the transmembrane pressure control system. -fl 08 - indicates pressure control failure and potential failure in the transmembrane pressure control system.
  • Action
    In the event of faults FL-04, FL-07 and FL-08 please contact your Authorized Service Provider or through Technical Service 0800-125522 - option 3. As in the case of a fault in ultrafiltration other than error codes FL-04, FL-07 and FL-08 and the dialyzer in use is not high flow, treatment can be continued through manual control of ultrafiltration provided that the treatment and patient are carefully monitored. Changes in the manuals are being carried out and will be sent to you. In addition, the SPS 1550 has a side panel that contains a 16-digit display. Currently in the event of a fault in the ultrafiltration system, the display shows "MANUAL UF CONTROL". To avoid future doubts to the operator, a new software version is being developed in order to display the message "DISCONTINUE TX" if one of the error codes FL-04, FL-07 or FL-08 occurs. The SPS 550 does not have an electronic side panel and therefore does not require a software upgrade.

Device

Hemodialysis machine, model SPS-550. Hemodialysis machine, model SPS-1550.

Manufacturer

BAXTER HOSPITALAR LTDA
  • Source
    ANVSANVISA