BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AUTOMATED IMPELLA CONTROLLER

    MDR report key: 19359864 · Received May 21, 2024

    Report

    Report Number
    1220648-2024-11471
    Event Type
    Malfunction
    Date Received
    May 21, 2024
    Date of Event
    May 10, 2024
    Report Date
    July 12, 2024
    Manufacturer
    ABIOMED, INC.
    Product Code
    OZD
    UDI-DI
    00813502010022
    PMA / PMN Number
    P140003
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE INVESTIGATION FOR THE REPORTED CONSOLE (AIC) BATTERY FAILURE (RED ALARM) HAS BEEN COMPLETED. THE CONSOLE WAS RETURNED FOR EVALUATION. FUNCTIONAL TESTING WAS PERFORMED AND FOUND THAT ON INITIAL BOOTUP, THE CONSOLE DISPLAYED ¿SYSTEM SELF CHECK FAILED.¿ UPON REVIEWING THE LOGS VIA TELNET, IT WAS CONFIRMED THAT THE REPORTED FAILURE MODE SYMPTOMS WERE REPRODUCED (COMMUNICATION ISSUE WITH POWERMOD_1). THE COMMUNICATION ISSUE WAS PERSISTENT. UPON VISUAL INSPECTION, A CABLE FROM PBM (J13) WAS NOT FULLY SEATED AT THE 4-IN-1 CONNECTOR (X45). THERE WAS NO PHYSICAL DAMAGE FOUND ON THE CONNECTOR. FURTHER TESTING OF THE AIC WAS PERFORMED BY RUNNING THE OPTICAL TEST PUMP FOR MORE THAN 24 HOURS AND THE CONTROLLER ERROR WAS NOT REPRODUCED. DATA LOGS WERE REVIEWED CONFIRMED THAT UPON SEVERAL MANUAL BOOT UPS, THE CONSOLE DISPLAYED ¿CONTROLLER ERROR (LOSS OF COMM (PBM1)) -ALARM¿, EVENT #1023. THE ROOT CAUSE FOR THE CONTROLLER ERROR WAS A LOOSE CABLE CONNECTION AT THE 4-IN-1 CONNECTOR (X45). ADDED- B5 MSO REVIEW, D9 DEVICE RETURN DATE.

    Additional Manufacturer Narrative · 0

    THE IMPELLA DEVICE WAS NOT RECEIVED FROM THE CUSTOMER AND THEREFORE, AN EVALUATION OF THE DEVICE WAS NOT POSSIBLE. UPON INVESTIGATION CLOSURE, A SUPPLEMENTAL MDR WILL BE FILED.

    Description of Event or Problem · 0

    IT WAS FURTHER REPORTED THAT CARE WAS WITHDRAWN FROM THE PATIENT AND THE PATIENT EXPIRED. THE PATIENT'S OUTCOME WAS REVIEWED BY ABIOMED'S MEDICAL SAFETY OFFICER (MSO) AND IT WAS DETERMINED THAT THERE WAS NOT ENOUGH INFORMATION TO ASSOCIATE USE OF THE DEVICE WITH THE OUTCOME.

    Description of Event or Problem · 0

    THE USER FACILITY REPORTED THAT THE AUTOMATED IMPELLA CONTROLLER (AIC) WHILE IN USE ANNUNCIATED "CONTROLLER ERROR" ALARMS FIVE TIMES BETWEEN DAY OF IMPLANT AND THE NEXT DAY. ADDITIONALLY, ON THE NEXT DAY, THE AIC BATTERY LEVEL INSTANTANEOUSLY DROP FROM 100% TO 0% AND THEN BACK TO 100%. THERE WAS NO REPORT OF PATIENT HARM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1220356 AUTOMATED IMPELLA CONTROLLER CONTROL, PUMP SPEED, CARDIOPULMONARY BYPASS OZD ABIOMED, INC. AUTOMATED IMPELLA CONTROLLER 1091702 00813502010022

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Female