BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANIVIA SG1000 PUMP CONSOLE

    MDR report key: 24959221 · Received April 22, 2026

    Report

    Report Number
    3015431638-2026-00001
    Event Type
    Malfunction
    Date Received
    April 22, 2026
    Date of Event
    March 24, 2026
    Report Date
    April 23, 2026
    Manufacturer
    APMTD, INC. .
    Product Code
    DWA
    UDI-DI
    00850000067059
    PMA / PMN Number
    K221491
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE INVESTIGATION INTO THE EVENT IS CURRENTLY ONGOING. A FOLLOW-UP MDR WILL BE SUBMITTED WHEN MORE INFORMATION BECOMES AVAILABLE.

    Description of Event or Problem · 0

    DURING A CASE, WHILE PUMPING IN CASE MODE, THE DCM SCREEN WENT BLACK. USER COULD NOT CONFIRM WHETHER THE PUMP CONTINUED SPINNING. USER MENTIONED A POSSIBLE AC CONNECTION ISSUE WITH THE POWER CORD PLUGGED INTO THE BOTTOM OF THE DCM. AFTER THE BLACK SCREEN OCCURRED, THE PERFUSIONIST HAND-CRANKED THE CASE TEMPORARILY UNTIL THEY COULD SWITCH TO A DIFFERENT ANIVIA SYSTEM. ALL OTHER CONNECTORS WERE CHECKED, AND THE AC POWER CORD WAS NOT FULLY PLUGGED IN. THE SYSTEM SHOULD HAVE CONTINUED RUNNING ON BATTERY IN THIS SITUATION, AND USER REPORTED THAT THE BATTERY WAS FULLY CHARGED WHEN PLUGGING IN THE MACHINE AFTERWARD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1020630 ANIVIA SG1000 PUMP CONSOLE CONTROL, PUMP SPEED CARDIOPULMONARY BYPASS DWA APMTD, INC. . 00850000067059

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other