BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANIVIA SG1000 PUMP CONSOLE

    MDR report key: 24938492 · Received April 21, 2026

    Report

    Report Number
    24938492
    Event Type
    Malfunction
    Date Received
    April 21, 2026
    Date of Event
    March 24, 2026
    Report Date
    April 13, 2026
    Manufacturer
    APMTD, INC.
    Product Code
    DWA
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    CA
    Reporter Occupation
    003

    Narratives

    Description of Event or Problem · 0

    ECMO [EXTRACORPOREAL MEMBRANE OXYGENATION] CONSOLE SHUTDOWN WITHOUT WARNING CAUSING PUMP TO POWER OFF. CCP [CERTIFIED CLINICAL PERFUSIONIST] ON SHIFT WAS BRIEFLY ATTEMPTING TO RESTORE POWER TO THE CONSOLE AND WHEN THEY WERE UNSUCCESSFUL, RETRIEVED A BACKUP CONSOLE WHICH WE THEN USED TO REPLACE THE FAILED CONSOLE. ON [REDACTED] WITH BACKUP CONSOLE: CIRCULATED PRIME AND RAN THE PUMP A COUPLE HOURS EARLIER. CALLED FOR AN ECMO INITIATION AND WITHIN 30 SECONDS OF UNPLUGGING FROM A/C POWER, THE CONSOLE DIED, SCREEN LOST POWER. OF NOTE, THE CONSOLE WAS NOT IN SLEEP MODE, PRIOR TO UNPLUGGING IT WAS SHOWING A FULLY CHARGED BATTERY, NO ODD ALARMS. IT DID THE NORMAL ALARM UPON UNPLUGGING FROM A/C POWER, WHICH I ACKNOWLEDGED, THEN BY THE TIME I HAD PUSHED IT TO THE TRAUMA ELEVATOR THE CONSOLE WAS DEAD. I PLUGGED IT BACK INTO A/C POWER AND UPON POWERING BACK UP, IT SHOWED A 100% CHARGED BATTERY. ATTEMPTED TO REPLICATE THE ISSUE, IT BEHAVED NORMALLY FOR 6-8 TIMES THEN IT FINALLY DIED AGAIN WITHIN MINUTES OF BEING UNPLUGGED THIS MORNING. WHILE DECANNULATING A PATIENT (AFTER SUPPORT WAS OFF) THE CONSOLE/ SCREEN SHUT OFF. ALSO NOTED THAT THE POWER CABLE UNDER THE MONITOR WAS LOOSE, AND THAT COULD HAVE CONTRIBUTED TO IT. EVEN IF THAT WAS LOOSE, THE BATTERY SHOULD HAVE KICKED IN TO PREVENT THE CONSOLE FROM SHUTTING OFF, BUT IT DID NOT.

    Description of Event or Problem · 0

    ECMO [EXTRACORPOREAL MEMBRANE OXYGENATION] CONSOLE SHUTDOWN WITHOUT WARNING CAUSING PUMP TO POWER OFF. CCP [CERTIFIED CLINICAL PERFUSIONIST] ON SHIFT WAS BRIEFLY ATTEMPTING TO RESTORE POWER TO THE CONSOLE AND WHEN THEY WERE UNSUCCESSFUL, RETRIEVED A BACKUP CONSOLE WHICH WE THEN USED TO REPLACE THE FAILED CONSOLE. ON [REDACTED] WITH BACKUP CONSOLE: CIRCULATED PRIME AND RAN THE PUMP A COUPLE HOURS EARLIER. CALLED FOR AN ECMO INITIATION AND WITHIN 30 SECONDS OF UNPLUGGING FROM A/C POWER, THE CONSOLE DIED, SCREEN LOST POWER. OF NOTE, THE CONSOLE WAS NOT IN SLEEP MODE, PRIOR TO UNPLUGGING IT WAS SHOWING A FULLY CHARGED BATTERY, NO ODD ALARMS. IT DID THE NORMAL ALARM UPON UNPLUGGING FROM A/C POWER, WHICH I ACKNOWLEDGED, THEN BY THE TIME I HAD PUSHED IT TO THE TRAUMA ELEVATOR THE CONSOLE WAS DEAD. I PLUGGED IT BACK INTO A/C POWER AND UPON POWERING BACK UP, IT SHOWED A 100% CHARGED BATTERY. ATTEMPTED TO REPLICATE THE ISSUE, IT BEHAVED NORMALLY FOR 6-8 TIMES THEN IT FINALLY DIED AGAIN WITHIN MINUTES OF BEING UNPLUGGED THIS MORNING. WHILE DECANNULATING A PATIENT (AFTER SUPPORT WAS OFF) THE CONSOLE/ SCREEN SHUT OFF. ALSO NOTED THAT THE POWER CABLE UNDER THE MONITOR WAS LOOSE, AND THAT COULD HAVE CONTRIBUTED TO IT. EVEN IF THAT WAS LOOSE, THE BATTERY SHOULD HAVE KICKED IN TO PREVENT THE CONSOLE FROM SHUTTING OFF, BUT IT DID NOT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1009650 ANIVIA SG1000 PUMP CONSOLE CONTROL, PUMP SPEED, CARDIOPULMONARY BYPASS DWA APMTD, INC. SG1000

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Female Other