BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AUTOMATED IMPELLA CONTROLLER

    MDR report key: 20919054 · Received December 12, 2024

    Report

    Report Number
    1220648-2024-24741
    Event Type
    Malfunction
    Date Received
    December 12, 2024
    Date of Event
    March 15, 2023
    Report Date
    December 12, 2024
    Manufacturer
    ABIOMED, INC.
    Product Code
    OZD
    UDI-DI
    00813502010022
    PMA / PMN Number
    P140003
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    CONSOLE LOGS FROM THE REPORTED DAY OF EVENT ARE CONSISTENT WITH COMPLAINT AND SHOW THAT AFTER 19 DAYS AND 18 HOURS OF SUPPORT WITH PUMP 430446, CONSOLE SUDDENLY PRESENTED WITH CONTROLLER FAILURE ALARM (#1027, SEEMINGLY DUE TO PBM1 SOFTWARE CORRUPTION), FOLLOWED BY BATTERY LEVEL LOW (#23) ALARM. AFTER CONSOLE WAS RECEIVED IN DANVERS, IT WOULD NOT BOOT-UP PROPERLY DUE TO SYSCALL ERROR (FW MISMATCH DETECTED). BY MANUALLY INITIALIZING PBM COMMUNICATION TO PBM1 AND PBM2 VIA TELNET COMMANDS IN SERVICE MODE, IT¿S BEEN OBSERVED THAT HW REVISION BIT FOR PBM1 HAD INCORRECT VALUE: SAU_POWERMOD_1 HW REVISION: -1 VERSION: E 0 PBM_CBH_2. SAU_POWERMOD_2 HW REVISION: 0 VERSION: E 0 PBM_CBH_2. AT THE SAME TIME, PBM FIRMWARE CONTENT EXTRACTED FROM BOTH CONTROLLERS ON THE BOARD WAS IDENTICAL, AND CONSISTENT WITH THE PROGRAMMING CODE (PBM_CBH_2). AFTER RESETTING THE HW REVISION BIT, THE CONSOLE WAS ABLE TO PROPERLY BOOT-UP, AND NO CONTROLLER ALARMS WERE PRESENT (AND BATTERY LEVEL WAS CORRECTLY REPORTED). ALTHOUGH THE HW REVISION BIT MAINTAINED ITS VALUE AFTER SEVERAL AIC RE-BOOTS, IT IS RECOMMENDED TO REPLACE PBM AS A PRECAUTION TO MINIMIZE CHANCES OF THE BIT RESETTING ITSELF SPONTANEOUSLY. THE CAUSE OF THE AIC ISSUE WAS A FIRMWARE CORRUPTION. THIS REPORT IS BEING FILED AS PART OF A RETROSPECTIVE REVIEW OF HISTORICAL RECORDS.

    Description of Event or Problem · 0

    THE COMPLAINANT REPORTED A PATIENT WITH CARDIOMYOPATHY WAS IMPLANTED WITH AN IMPELLA 5.5 FOR MECHANICAL CIRCULATORY SUPPORT. IT WAS REPORTED DURING IMPELLA 5.5 SUPPORT, THE AUTOMATED IMPELLA CONTROLLER (AIC) PRESENTED WITH A CONTROLLER FAILURE ALARM. THE AIC WAS EXCHANGED FOR A BACKUP UNIT AND THE ISSUE WAS RESOLVED. THERE WAS NO PATIENT HARM REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1936739 AUTOMATED IMPELLA CONTROLLER TEMPORARY NON-ROLLER TYPE LEFT HEART SUPPORT BLOOD PUMP OZD ABIOMED, INC. AUTOMATED IMPELLA CONTROLLER 1103170 00813502010022

    Patients

    Seq Age Sex Outcome Treatment
    1 38 YR Male