BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AUTOMATED IMPELLA CONTROLLER

    MDR report key: 20614078 · Received November 5, 2024

    Report

    Report Number
    1220648-2024-22115
    Event Type
    Malfunction
    Date Received
    November 5, 2024
    Date of Event
    July 10, 2021
    Report Date
    November 5, 2024
    Manufacturer
    ABIOMED, INC.
    Product Code
    OZD
    UDI-DI
    00813502011401
    PMA / PMN Number
    P140003
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    BIOMEDICAL ENGINEER
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    CONSOLE LOGS FROM THE REPORTED DAY OF EVENT ARE CONSISTENT WITH COMPLAINT AND SHOW THAT ALARM#: 603 (UNEXPECTED CONTROLLER SHUTDOWN) WAS SHOWN, 13 DAYS AFTER SUPPORT STARTED (ON (B)(6) 2021). THIS ALARM WAS A CONSEQUENCE OF CONSOLE SELF-RESET (AND SELF-RESTART) FOLLOWING CRASH OF IO-GRAPHICS PROCESS (PART OF QNX), WHICH WAS DETECTED BY AIC SOFTWARE: ON (B)(6) 2021 08:29:56: SYSTEMIDLE: PROCESS IO-GRAPHICS 339995 DIED ABNORMALLY THIS SELF-RESET IS A MITIGATION MECHANISM FOR WHEN IO-GRAPHICS CRASHES, THAT HAS BEEN IMPLEMENTED IN AIC_V8.2 IN RESPONSE TO A SERIES OF COMPLAINTS REGARDING THAT FAILURE MODE (JAMA: GID-DFT-863138). DURING AND AFTER THE RESET, HEMODYNAMIC SUPPORT CONTINUED. CONSOLE OPERATED WITHIN SPECIFICATION, AND THE ISSUE WAS RESOLVED. THIS REPORT IS BEING FILED AS PART OF A RETROSPECTIVE REVIEW OF HISTORICAL RECORDS.

    Description of Event or Problem · 0

    THE COMPLAINANT REPORTED A PATIENT WAS IMPLANTED WITH AN IMPELLA 5.5 FOR MECHANICAL CIRCULATORY SUPPORT. WHILE ON SUPPORT, THE AUTOMATED IMPELLA CONTROLLER (AIC) EXPERIENCED AN UNEXPECTED SHUTDOWN. THE CONSOLE WAS REPLACED TO ADDRESS THE ISSUE. NO PATIENT HARM REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1405261 AUTOMATED IMPELLA CONTROLLER CONTROL, PUMP SPEED, CARDIOPULMONARY BYPASS OZD ABIOMED, INC. AUTOMATED IMPELLA CONTROLLER 1570900 00813502011401

    Patients

    Seq Age Sex Outcome Treatment
    1 20 YR Male