BEUDAMED
    FDA Adverse Event Death Summary report: N

    AUTOMATED IMPELLA CONTROLLER

    MDR report key: 21697756 · Received March 26, 2025

    Report

    Report Number
    1220648-2025-26971
    Event Type
    Death
    Date Received
    March 26, 2025
    Date of Event
    March 3, 2025
    Report Date
    May 2, 2025
    Manufacturer
    ABIOMED, INC
    Product Code
    OZD
    UDI-DI
    00813502010022
    PMA / PMN Number
    P170011
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE AUTOMATED IMPELLA CONTROLLER (AIC) WAS RETURNED, AND AN EVALUATION IS UNDERWAY. UPON INVESTIGATION CLOSURE, A SUPPLEMENTAL MANUFACTURER DEVICE REPORT WILL BE FILED.

    Additional Manufacturer Narrative · 0

    THE INVESTIGATION OF AUTOMATED IMPELLA CONTROLLER (AIC) - CONTROLLER ERROR (YELLOW ALARM) AND AIC - LOSS OF OPM DATA HAS BEEN COMPLETED. DATA ANALYSIS: ON 3/2 RP PUMP WITH CONSOLE IC5202, IMMEDIATELY UNPLUGGED, THEN PLUGGED BACK IN. AFTER THE PUMP WAS PLUGGED BACK IN, ON 3/3, THE LOGS SHOW TWO COMMANDS "PROCESSSAMPLINGDATAFROMOPTICALBENCH: SENTSTOPACQUISITIONCMD ACK" THEN "CLEARALLOPTICALDATASHAREDMEMORY: 0X4000". THIS RESULTS IN "PROCESSDUALSENSORSAMPLEFOROPMCOMMSTOPPEDERROR: CALCULATOR PLACEMENT SIGNAL 1058" WHICH IS INDICATIVE OF THE FAILURE MODE LOSS OF OPTICAL DATA DUE TO A SOFTWARE DEFECT. THE REAL TIME (RT) LOGS CONFIRMED NO OPTICAL DATA AT THIS TIME. THE PUMP STAYED ON THIS CONSOLE UNTIL THE END OF THE CASE ON 3/6 DESPITE THE LACK OF OPTICAL SIGNAL. DEVICE ANALYSIS: THE CONSOLE WAS TESTED ON AN ENGINEERING LAB BENCH. THE FAILURE MODE WAS NOT REPRODUCED WHILE RUNNING AN OPTICAL PUMP SIMULATOR. THERE WAS NO ISSUE WITH THE CONSOLE HARDWARE. ROOT CAUSE: THE ROOT CAUSE OF THE CONTROLLER ERROR WAS DUE TO AN AIC SOFTWARE ISSUE. THIS WAS ENTERED INTO JAMA WITH DEFECT/ BUG ID GID-DFT-2927090.

    Additional Manufacturer Narrative · 0

    G.4 REVISED PMA/510(K) NUMBER AS IT WAS PREVIOUSLY ENTERED INCORRECTLY ON THE INITIAL MANUFACTURER DEVICE REPORT NUMBER 1220648-2025-26971.

    Description of Event or Problem · 0

    THE COMPLAINANT REPORTED A PATIENT WAS IMPLANTED WITH AN IMPELLA RP FLEX AND IMPELLA CP BIPELLA DEVICE FOR MECHANICAL CIRCULATORY SUPPORT. THE PUMP WAS PLACED AND HAD AN AUTOMATED IMPELLA CONTROLLER (AIC) ALARM FOR OPTICAL SIGNAL FOLLOWED BY A YELLOW CONTROLLER ALARM. AFTER 96 HOURS OF SUPPORT, THE DECISION WAS MADE BY THE FAMILY TO WITHDRAW CARE AND THE PATIENT EXPIRED. IT IS UNKNOWN IF THE USE OF THE IMPELLA WAS RELATED TO PATIENT DEATH, THUS THERE IS NOT ENOUGH EVIDENCE TO EXCLUDE THE IMPELLA AS AN ASSOCIATED FACTOR IN THE PATIENT'S OUTCOME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1804763 AUTOMATED IMPELLA CONTROLLER TEMPORARY NON-ROLLER TYPE RIGHT HEART SUPPORT BLOOD PUMP OZD ABIOMED, INC AUTOMATED IMPELLA CONTROLLER 1292326 00813502010022

    Patients

    Seq Age Sex Outcome Treatment
    1 81 YR Male Death IMPELLA RP FLEX.