Alerta De Seguridad para Hemodialysis machine, model SPS-550. Hemodialysis machine, model SPS-1550.

Safety alert

720

2003-03-25

Brazil

ANVISA

http://www.anvisa.gov.br/sistec/alerta/consultaralerta.asp

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.

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.