BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AUTOMATED IMPELLA CONTROLLER

    MDR report key: 20966588 · Received December 18, 2024

    Report

    Report Number
    1220648-2024-24885
    Event Type
    Malfunction
    Date Received
    December 18, 2024
    Date of Event
    May 7, 2023
    Report Date
    December 18, 2024
    Manufacturer
    ABIOMED, INC.
    Product Code
    OZD
    PMA / PMN Number
    P140003
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    AUTOMATED IMPELLA CONTROLLER (CONSOLE) LOGS FROM THE REPORTED DAY OF EVENT ARE PARTIALLY CONSISTENT WITH COMPLAINT AND SHOW THAT DURING CASE START THE CONSOLE WAS UNABLE TO PRIME THE LINE, BUT - CONTRARY TO THE COMPLAINT DESCRIPTION - THERE WERE NO ¿PUMP FAILURE¿ ALARMS, BUT RATHER ¿PURGE SYSTEM FAILURE¿ ALARMS (#417, DUE TO PISTON BLOCKED), AS WELL AS MULTIPLE ERROR MESSAGES RELATED TO PURGE IRREGULARITIES: PISTON BLOCKED, HOME NOT FOUND, AND PURGE FLUID NOT DETECTED. IMC LOG ENTRIES ALSO INDICATE PUD/SAU_PURGE COMMUNICATION ISSUES AND PUD RESETS. INSPECTION OF THE CONSOLE REVEALED PURGE MOTOR SHAFT BEING IMMOBILIZED AND DEXTROSE RESIDUE WAS FOUND UNDER THE MOTOR SHAFT GASKET. THIS IS CONSISTENT WITH PUD COMMUNICATION LOSS DUE TO INCREASED CURRENT DRAW FROM MOTOR, RESULTING IN PBM CIRCUTRY (POWER REGULATOR ON PBM) LIMITING (OR ¿LOCKING OUT¿) VOLTAGE TO PUD PCA. IMMOBILIZED MOTOR SHAFT WAS UNABLE TO ACTUATE PURGE CASSETTE PISTON, AND PURGE FLUID WAS NOT FLOWING, AS EVIDENCED BY VERY LOW PURGE PRESSURE MEASUREMENT (BELOW 100MMHG THRESHOLD FOR OPEN LINE). THE CAUSE OF THE CONSOLE ISSUE WAS CONTAMINATION OF THE MOTOR SHAFT GASKET WHICH IMMOBILIZED THE SHAFT, PREVENTING PURGE OPERATION. THIS REPORT IS BEING FILED AS PART OF A RETROSPECTIVE REVIEW OF HISTORICAL RECORDS.

    Description of Event or Problem · 0

    THE COMPLAINANT REPORTED THAT AN AUTOMATED IMPELLA CONTROLLER (AIC) IN USE FOR A CLINICAL PROCEDURE ALARMED FOR "PURGE CASSETTE PRIMING NOT POSSIBLE" AND "PUMP FAILURE ALARM". THE AIC WAS REPLACED WITH A BACK UP UNIT TO RESOLVE THE ISSUE. NO PATIENT INFORMATION WAS PROVIDED, NO PATIENT HARM WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1987840 AUTOMATED IMPELLA CONTROLLER TEMPORARY NON-ROLLER TYPE LEFT HEART SUPPORT BLOOD PUMP OZD ABIOMED, INC. AUTOMATED IMPELLA CONTROLLER 1404002

    Patients

    Seq Age Sex Outcome Treatment
    1 0 DA Unknown