BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AUTOMATED IMPELLA CONTROLLER

    MDR report key: 20598908 · Received November 4, 2024

    Report

    Report Number
    1220648-2024-21849
    Event Type
    Malfunction
    Date Received
    November 4, 2024
    Date of Event
    November 14, 2022
    Report Date
    November 4, 2024
    Manufacturer
    ABIOMED, INC.
    Product Code
    OZD
    UDI-DI
    00813502011401
    PMA / PMN Number
    P140003
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE INVESTIGATION INTO THE CONTROLLER FAILURE (RED ALARM) ISSUE HAS BEEN COMPLETED. THE AUTOMATED IMPELLA CONTROLLER (AIC) WAS RETURNED FOR INVESTIGATION. CONSOLE LOGS FROM THE REPORTED DAY OF EVENT ARE CONSISTENT WITH COMPLAINT AND SHOW A CONTROLLER FAILURE ALARM AFTER 8 DAYS OF SUPPORT WITH PUMP 395280. THE ALARM WAS PRECEDED BY SEVERAL SAU_PURGE COMMUNICATION ERROR MESSAGES, AND FOLLOWED BY ALARMS #501 (CONTROLLER ERROR DUE TO PBM VOLTAGE OUT-OF-SPEC), AND FAILED RESETS OF PUD. THE ISSUE WAS REPRODUCED. INSPECTION OF THE ELECTRONICS REVEALED THAT ALTHOUGH PBM WAS PROVIDING NOMINAL VOLTAGE TO THE PUD (24V BETWEEN PIN5 AND PIN4 ON J1.1 ON PUD PCA), THE GREEN LED ON PUD WAS NOT LIT, INDICATING FAILURE OF PUD. AFTER THE BOARD WAS TEMPORARILY REPLACED WITH A KNOWN-GOOD ONE, THE ISSUES WAS RESOLVED, AND THE PUD (SAU_PURGE) COMMUNICATION WAS ACTIVE. ANY PBM-RELATED ALARMS (#501) OBSERVED IN LOGS WERE RELATED TO THE PUD MALFUNCTION AND WERE ALSO RESOLVED WITH A PUD REPLACEMENT. THE CAUSE OF THE ISSUE WAS A DEFECTIVE COMPONENT. THIS REPORT IS BEING FILED AS PART OF A RETROSPECTIVE REVIEW OF HISTORICAL RECORDS.

    Description of Event or Problem · 0

    THE USER FACILITY REPORTED A PATIENT IN ACUTE MYOCARDIAL INFARCTION/CARDIOGENIC SHOCK ON AN AUTOMATED IMPELLA CONTROLLER (AIC) FOR MECHANICAL CIRCULATORY SUPPORT. A CONTROLLER FAILURE ALARM WAS NOTED ON THE AIC. THE INITIAL DEVICE WAS REPLACED WITH A NEW CONTROLLER. THERE WAS NO REPORT OF PATIENT HARM OR INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2166861 AUTOMATED IMPELLA CONTROLLER CONTROL, PUMP SPEED, CARDIOPULMONARY BYPASS OZD ABIOMED, INC. AUTOMATED IMPELLA CONTROLLER 2023250798 00813502011401

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Female