BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AUTOMATED IMPELLA CONTROLLER

    MDR report key: 22159398 · Received June 6, 2025

    Report

    Report Number
    1220648-2025-29079
    Event Type
    Malfunction
    Date Received
    June 6, 2025
    Date of Event
    June 3, 2025
    Report Date
    July 11, 2025
    Manufacturer
    ABIOMED, INC.
    Product Code
    OZD
    UDI-DI
    00813502010428
    PMA / PMN Number
    P140003
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE INVESTIGATION OF AUTOMATED IMPELLA CONTROLLER (AIC) - BATTERY CHARGING/OTHER ISSUES AND AIC - SHUTDOWN OR RESTART ISSUE HAS BEEN COMPLETED. DATA ANALYSIS: THE CONSOLE LOGS SHOWED THE QNX PROCESS IO-GRAPHICS CRASHED WHICH CAUSED THE AIC SOFTWARE TO REBOOT. THIS REBOOT WAS ACCOMPANIED BY AN UNEXPECTED SHUTDOWN ALARM, AND THE PUMP FLOW DECREASED TO ZERO BEFORE IT WAS RESUMED AT THE PREVIOUS P-LEVEL PUMP FLOW. THERAPY CONTINUED FOR NEXT 15 MINS BEFORE THE PUMP WAS UNPLUGGED, AND THE CONSOLE WAS THEN POWERED DOWN. DEVICE ANALYSIS: THE FAILURE MODE WAS NOT REPRODUCED DURING INVESTIGATION ON ENGINEERING LAB BENCH. THE IO-GRAPHICS WAS FORCE SHUTDOWN USING A TELNET COMMAND AND THE CONSOLE RESPONDED THE SAME AS IN THE FIELD. ADDITIONALLY, THE OPTICAL BENCH WAS EXAMINED FOR 5S PARAMETERS, WHICH WERE FOUND TO BE WITHIN SPECIFICATION. AIC WAS RUN WITH KNOW GOOD PUMP AND PURGE CASSETTE FOR A FEW HOURS, AND NO ISSUES WERE FOUND. ROOT CAUSE THE CAUSE OF THE AIC ISSUE (UNEXPECTED SHUTDOWN ALARM) WAS THE 3RD PARTY HARDWARE/SOFTWARE THAT RUNS IO-GRAPHICS. ROOT CAUSE AIC - BATTERY CHARGING/OTHER ISSUES: THERE WAS NO ISSUE FOUND DURING THE CASE. THE DEVICE FUNCTIONED/OPERATED TO SPECIFICATION.

    Additional Manufacturer Narrative · 0

    THE CONSOLE WAS RETURNED, AND AN EVALUATION IS UNDERWAY. UPON INVESTIGATION CLOSURE, A SUPPLEMENTAL MANUFACTURER DEVICE REPORT WILL BE FILED.

    Description of Event or Problem · 0

    THE USER FACILITY REPORTED THE AUTOMATED IMPELLA CONTROLLER (AIC) THERE HAD AN ALARM FOR THE CONTROL UNIT. IT WAS REPORTED AS A BATTERY ISSUE. THE AIC WAS FORCIBLY SHUT DOWN. IT WAS STATED THE PATIENT'S HEMODYNAMICS WERE STABLE. THE PATIENT REMAINED ON SUPPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1479866 AUTOMATED IMPELLA CONTROLLER TEMPORARY NON-ROLLER TYPE LEFT HEART SUPPORT BLOOD PUMP OZD ABIOMED, INC. AUTOMATED IMPELLA CONTROLLER 1316946 00813502010428

    Patients

    Seq Age Sex Outcome Treatment
    1 0 DA Unknown