BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AUTOMATED IMPELLA CONTROLLER

    MDR report key: 22144950 · Received June 4, 2025

    Report

    Report Number
    1220648-2025-29003
    Event Type
    Malfunction
    Date Received
    June 4, 2025
    Date of Event
    May 12, 2025
    Report Date
    August 26, 2025
    Manufacturer
    ABIOMED, INC.
    Product Code
    OZD
    UDI-DI
    00813502011289
    PMA / PMN Number
    P140003
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IS
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE IMPELLA DEVICE HAS BEEN RECEIVED BUT HAS NOT YET BEEN EVALUATED. WHEN THE DEVICE INVESTIGATION HAS BEEN COMPLETED OR ANY NEW INFORMATION HAS BEEN RECEIVED, A SUPPLEMENTAL MDR WILL BE FILED.

    Additional Manufacturer Narrative · 0

    THE INVESTIGATION HAS BEEN COMPLETED. THE IMPELLA PUMP WAS RETURNED FOR INVESTIGATION. ON THE COMPLAINT DATE, ONE HOUR AFTER THE SUPPORT WAS INITIATED WITH PUMP SN: (B)(6), THE EPM COMMUNICATION ISSUE LED TO A RESET OF THE EPM. AFTER THE RESET, DUE TO THE PERSISTENT EPM COMMUNICATION ISSUE, THE CONSOLE DISPLAYED ¿CONTROLLER ERROR (LOSS OF COMM (EPM)) ¿ ALARM,¿ EVENT #1021 (IMC_LOGS_IC3818.PDF). THIS CONFIRMS THE REPORTED FAILURE MODE. THE CONSOLE THEN DISPLAYED ¿CONTROLLER ERROR (PBM VOLTAGE OUT-OF-SPEC) ¿ ALARM,¿ EVENT #501, DUE TO THE ABNORMAL VPCH1 VOLTAGE, INDICATING THAT THE EPM IS DRAWING MORE CURRENT BEYOND THE THRESHOLD OF 209MA. BECAUSE OF THE EPM COMMUNICATION ISSUE, THE PUMP DISCONNECTION WAS NOT RECOGNIZED, AND THE USER COULD NOT SHUT DOWN THE CONSOLE IN THE NORMAL WAY. HENCE, THE CONSOLE WAS SHUT DOWN BY DISENGAGING THE BATTERY SWITCH WHEN THERE WAS NO AC POWER. THE CONSOLE WAS TESTED AFTER ARRIVING AT FS. UPON THE INITIAL BOOTUP, THE CONSOLE REBOOTED AUTOMATICALLY DUE TO AN EPM COMMUNICATION ISSUE. AFTER THE REBOOT, BECAUSE OF THE PERSISTENT EPM COMMUNICATION ISSUE, THE CONSOLE DISPLAYED THE "SYSTEM SELF CHECK FAILED" SCREEN. THE RIBBON CABLE BETWEEN THE IMPELLATRONIC BOARD AND THE 4-IN-1 WAS CONNECTED PROPERLY. THE FIRMWARE CHECK VIA TELNET CONFIRMED THAT THE EPM WAS NOT COMMUNICATING WITH THE 4-IN-1. UPON REPLACING THE ORIGINAL IMPELLATRONIC BOARD WITH A KNOWN GOOD ONE, THE CONSOLE BOOTED UP AS INTENDED. WHILE RUNNING THE OPTICAL TEST PUMP, NO CONTROLLER ERROR WAS REPRODUCED. THE ROOT CAUSE OF THE CONTROLLER ERROR WAS AN IMPELLATRONIC BOARD MALFUNCTION. .

    Description of Event or Problem · 0

    THE USER FACILITY REPORTED THAT UPON INSERTING AN IMPELLA 5.5 PUMP, A CONTROLLER ERROR APPEARED ON THE AIC COINCIDING WITH A PROMPT TO SWITCH TO A BACKUP CONTROLLER. THE AIC WAS SWAPPED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT HARM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1064692 AUTOMATED IMPELLA CONTROLLER TEMPORARY NON-ROLLER TYPE LEFT HEART SUPPORT BLOOD PUMP OZD ABIOMED, INC. AUTOMATED IMPELLA CONTROLLER 1199628 00813502011289

    Patients

    Seq Age Sex Outcome Treatment
    1 0 DA Unknown