BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AUTOMATED IMPELLA CONTROLLER

    MDR report key: 20612840 · Received November 5, 2024

    Report

    Report Number
    1220648-2024-22038
    Event Type
    Malfunction
    Date Received
    November 5, 2024
    Date of Event
    May 9, 2022
    Report Date
    November 5, 2024
    Manufacturer
    ABIOMED, INC.
    Product Code
    OZD
    UDI-DI
    00813502010022
    PMA / PMN Number
    P140003
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MT, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE INVESTIGATION INTO THE BATTERY FAILURE ISSUE HAS BEEN COMPLETED. THE IMPELLA AUTOMATED CONTROLLER (AIC) WAS RETURNED FOR INVESTIGATION. THE DATA ANALYSIS OF THE LOGS REVEALED CONSISTENCY WITH THE REPORTED ISSUE, SUBSEQUENT BOOTS FOLLOWING THE COMPLAINT DATE TRIGGER THESE ALARMS. THE LONG-TERM LOGS WERE NOT AVAILABLE FOR REVIEW, HOWEVER A BATT TEST WAS PERFORMED VIA TELNET, REVEALING THAT CELL 1 OF BATTERY 1 HAD BEGUN TO DECLINE, PASSING THE OPERATING PARAMETERS OF THE BATTERY. DURING BENCH TESTING OF THE RETURNED CONSOLE, IT WAS CONFIRMED THAT THE PERSISTENT BATTERY FAILURE (TRANSPORT CONNECTION BLOWN/MISSING) WAS NOT DUE TO A DISENGAGED BATTERY SWITCH. WHEN THE RETURNED CONSOLE WAS BOOTED FOR THE FIRST TIME, CONSOLE ALARMS WERE CONSISTENT WITH WHAT WAS SEEN IN THE FIELD. WHEN VISUALLY INSPECTING THE BATTERIES AND THE POWER BATTERY MANAGER CIRCUIT BOARD, IT WAS OBSERVED THAT ONE OF THE BATTERIES¿ STATUS LIGHT-EMITTING DIODES WERE COMPLETELY BLANK. THE BATTERY FAILURE ALARM WAS DUE TO A DEFECTIVE BATTERY 2 (DECLINE OF INDIVIDUAL CELL VOLTAGE). THE ROOT CAUSE OF THE BATTERY CELL FAILURE WAS UNDETERMINED. THE CAUSE OF THE AIC ISSUE WAS A DEFECTIVE BATTERY, DUE TO THE DECLINE OF SINGLE CELL WITHIN BATTERY TWO. THIS REPORT IS BEING FILED AS PART OF A RETROSPECTIVE REVIEW OF HISTORICAL RECORDS.

    Description of Event or Problem · 0

    THE CLINICAL TRAINER REPORTED THAT THE AUTOMATED IMPELLA CONTROLLER (AIC) GENERATED A BATTERY FAILURE ALARM THAT DID NOT RESOLVE WITH CHARGING OR CYCLING THE CONSOLE BATTERY ON AND OFF. REPORTEDLY THERE WAS NO PATIENT OR PUMP INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    46660 AUTOMATED IMPELLA CONTROLLER CONTROL, PUMP SPEED, CARDIOPULMONARY BYPASS OZD ABIOMED, INC. AUTOMATED IMPELLA CONTROLLER 1186350 00813502010022

    Patients

    Seq Age Sex Outcome Treatment
    1 0 DA Unknown