BEUDAMED
    FDA Adverse Event Death Summary report: N

    AUTOMATED IMPELLA CONTROLLER

    MDR report key: 20645487 · Received November 8, 2024

    Report

    Report Number
    1220648-2024-22731
    Event Type
    Death
    Date Received
    November 8, 2024
    Date of Event
    February 14, 2022
    Report Date
    December 26, 2024
    Manufacturer
    ABIOMED, INC.
    Product Code
    OZD
    UDI-DI
    00813502010022
    PMA / PMN Number
    P140003
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    AUTOMATED IMPELLA CONTROLLER (CONSOLE) LOGS FROM THE REPORTED DAY OF EVENT ARE CONSISTENT WITH COMPLAINT AND SHOW AN ALARM "PLACEMENT SIGNAL NOT RELIABLE" (#1036) 2H43M AFTER PUMP (B)(4) WAS STARTED. THE OPERATOR(S) DISABLED PLACEMENT MONITORING, AND SUPPORT CONTINUED FOR ANOTHER 10 HOURS. REAL TIME LOG DATA CONFIRMS THAT RAW OPTICAL PLACEMENT SIGNAL FROM THAT MOMENT FORWARD HAD VALUE OF -32768 AND SNR WAS REPORTED AS 0. WHEN THE CONSOLE WAS POWERED-UP ON THE NEXT DAY, THE OPTICAL BENCH MALFUNCTION WAS MANIFESTED UPON BOOT-UP WITH ALARMS GENERATED. THERE IS ALSO EVIDENCE OF AN UNSUCCESSFUL ATTEMPT TO DOWNLOAD CONSOLE LOGS VIA USB. AFTER CONSOLE WAS BROUGHT TO DANVERS, THE PLACEMENT SIGNAL ISSUE WAS IMMEDIATELY REPRODUCED, AND IDENTIFIED AS OPTICAL BENCH FAILURE, RESULTING IN INCREASED CURRENT DRAW, CAUSING PBM TO REDUCE SUPPLY VOLTAGE WHICH, IN TURN, CAUSES THE BENCH TO BE UNABLE TO COMMUNICATE AND POWER THE LAMP. AFTER THE OPTICAL BENCH WAS REPLACED, THE ISSUE WAS RESOLVED. INABILITY TO DOWNLOAD DATA ON THE USB STICK WAS NOT REPRODUCED DURING TESTING (USING EITHER USB PORT ON THE CONSOLE'S I/O PANEL OR THE USB PORT ON THE BACK OF RLM), AND WAS MOST LIKELY CAUSED BY A DEFECTIVE USB STICK USED BY OPERATOR(S). THE CAUSE OF THE CONSOLE ISSUE WAS A DEFECTIVE OPTICAL BENCH. THIS REPORT IS BEING FILED AS PART OF A RETROSPECTIVE REVIEW OF HISTORICAL RECORDS.

    Additional Manufacturer Narrative · 0

    THE AIC (AUTOMATED IMPELLA CONTROLLER) DEVICE WAS RETURNED, AND AN EVALUATION IS UNDERWAY. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED. 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 IN ACUTE MYOCARDIAL INFARCTION/CARDIOGENIC SHOCK WAS IMPLANTED WITH AN IMPELLA CP DEVICE FOR MECHANICAL CIRCULATORY SUPPORT. THE COMPLAINANT REPORTED A CONSOLE FAILURE WHEN ATTEMPTING TO DOWNLOAD THE LOGS FOR A SENSOR COMPLAINT THAT OCCURRED ON THIS DEVICE. REBOOTED SEVERAL TIMES AND STILL HAD THE SAME ISSUE. IN ADDITION, WHEN SETTING UP THE CATHETER, A CALIBRATING SENSOR SCREEN APPEARED. ADDITIONAL INFORMATION WAS PROVIDED THAT NOTED THE PATIENT EXPIRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1849197 AUTOMATED IMPELLA CONTROLLER CONTROL, PUMP SPEED, CARDIOPULMONARY BYPASS OZD ABIOMED, INC. AUTOMATED IMPELLA CONTROLLER 1219724 00813502010022

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Male Death