BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AUTOMATED IMPELLA CONTROLLER

    MDR report key: 21157451 · Received January 15, 2025

    Report

    Report Number
    1220648-2025-25576
    Event Type
    Malfunction
    Date Received
    January 15, 2025
    Date of Event
    December 20, 2024
    Report Date
    February 20, 2025
    Manufacturer
    ABIOMED, INC.
    Product Code
    OZD
    UDI-DI
    00813502011401
    PMA / PMN Number
    P140003
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE INVESTIGATION FOR THE CONSOLE (AIC) BATTERY FAILURE-RED ALARM HAS BEEN COMPLETED. DATA LOGS WERE REVIEWED FINDING THAT DURING THE SUPPORT, THE CONSOLE DISPLAYED ¿BATTERY FAILURE (TRANSPORT CONNECTION BLOWN/MISSING) ¿ ALARM,¿ EVENT #360. THIS CONFIRMS THE REPORTED FAILURE MODE. AFTER A FEW MINUTES, THE CONSOLE ALSO DISPLAYED THE ¿BATTERY LEVEL LOW (50%) ¿ ALARM,¿ EVENT #23. THE CONSOLE WAS RETURNED FOR EVALUATION. THE REPORTED FAILURE MODE OF BATTERY FAILURE WAS REPRODUCED. BATTERY 2¿S LCD SCREEN WAS BLINKING. THE BATTTEST UTILITY VIA TELNET CONFIRMED THE CELL IMBALANCE WITH CELL 2 OF BATTERY 2. UPON REPLACING THE ORIGINAL BATTERIES WITH KNOWN GOOD ONES, THERE WAS NO BATTERY FAILURE ALARM, AND THE BATTERIES WERE ABLE TO CHARGE. THE ROOT CAUSE OF THE BATTERY FAILURE ALARM WAS A SINGLE CELL FAILURE.

    Additional Manufacturer Narrative · 0

    THE AUTOMATED IMPELLA CONTROLLER HAS BEEN RECEIVED FROM THE CUSTOMER; HOWEVER, THE EVALUATION OF THE DEVICE IS NOT COMPLETE. UPON INVESTIGATION CLOSURE, A SUPPLEMENTAL MDR WILL BE FILED. THIS IS ONE OF TWO MEDICAL DEVICE REPORTS RELATED TO THE PATIENT IMPLANT EXPERIENCE. REFER TO INITIAL MEDICAL DEVICE REPORT FOR THE IMPELLA 5.5 DEVICE SERIAL NUMBER (B)(6) WITH DATE OF EVENT 20-DEC-2024 AND IDENTIFIER ENDING IN (B)(6) .

    Description of Event or Problem · 0

    THE USER FACILITY REPORTED A PATIENT 38-WEEK PREGNANT PATIENT WITH CARDIOMYOPATHY WAS IMPLANTED WITH AN IMPELLA 5.5 DEVICE FOR MECHANICAL CIRCULATORY SUPPORT (MCS) AND WHILE ON SUPPORTED THE AUTOMATED IMPELLA CONTROLLER EXPERIENCED A PERSISTENT BATTERY FAILURE ALARM. THE PATIENT PRESENTED TO THE EMERGENCY DEPARTMENT ONE DAY PRIOR WITH PALPITATIONS AND CHEST PAIN ELECTROCARDIOGRAM SHOWED ST-ELEVATION MYOCARDIAL INFARCTION VERSUS MYOCARDITIS. CATHETERIZATION WAS COMPLETED AND RULED OUT BLOCKAGES. THE FOLLOWING DAY THE PATIENT WAS IMPLANTED WITH AN IMPELLA 5.5 DEVICE NOW ON VENOARTERIAL EXTRACORPOREAL MEMBRANE OXYGENATION AND IMPELLA MCS (ECPELLA). THE PATIENT WAS NOTED ON CONTINUOUS RENAL REPLACEMENT THERAPY AS WELL. THE FOLLOWING DAY IN THE MORNING TISSUE PLASMINOGEN ACTIVATOR (TPA) WAS STARTED DUE TO ELEVATED PURGE PRESSURE ABOVE 1100 AND PURGE FLOW AROUND 2.4. WITH TPA, FLOWS WERE NOTED TO BE IMPROVING. THE PATIENT CONTINUED ON ECPELLA SUPPORT WITH WORK UP FOR ORTHOTOPIC HEART TRANSPLANTATION WITH HOPES OF RECOVERY. NOW 12 DAYS ON SUPPORT, THE NURSE REPORTED AUTOMATED IMPELLA CONTROLLER (AIC) HAD A BATTERY FAILURE. THE BATTERY WAS AT 50%, IT WAS PLUGGED BACK IN, BUT THE ALARM CONTINUED. IT WAS INDICATED THE AIC WAS REPLACED. THE PATIENT WAS EVENTUALLY DECANNULATED AND IMPELLA 5.5 DEVICE WAS SUCCESSFULLY WEANED AND EXPLANTED IN THE CARDIOVASCULAR OPERATING ROOM AFTER A TOTAL OF 14 DAYS ON SUPPORT. THE OUTCOME OF THE PATIENT FOLLOWING THE EVENT IS UNKNOWN. HOWEVER, THERE WAS NO REPORT OF HARM RESULTING FROM THE AIC FAILURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    931793 AUTOMATED IMPELLA CONTROLLER TEMPORARY NON-ROLLER TYPE LEFT HEART SUPPORT BLOOD PUMP OZD ABIOMED, INC. AUTOMATED IMPELLA CONTROLLER 1471020 00813502011401

    Patients

    Seq Age Sex Outcome Treatment
    1 25 YR Female