BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AUTOMATED IMPELLA CONTROLLER

    MDR report key: 20578433 · Received October 31, 2024

    Report

    Report Number
    1220648-2024-21651
    Event Type
    Malfunction
    Date Received
    October 31, 2024
    Date of Event
    May 26, 2021
    Report Date
    October 31, 2024
    Manufacturer
    ABIOMED, INC.
    Product Code
    OZD
    UDI-DI
    00813502010022
    PMA / PMN Number
    P140003
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    BIOMEDICAL ENGINEER
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE WAS RETURNED AND EVALUATED, AND THE INVESTIGATION FOR THE REPORTED CONTROLLER ERROR (YELLOW ALARM) HAS BEEN COMPLETED. CONSOLE LOGS FROM THE REPORTED DAY OF EVENT ARE CONSISTENT WITH COMPLAINT AND SHOW A SINGLE OCCURRENCE OF KBD COMMUNICATION ERROR FOLLOWED BY ALARM #24 (LOSS OF COMMUNICATION WITH KBD). CONSOLE WAS POWERED ON AGAIN, THE NEXT DAY, BUT THE ALARM DID NOT REOCCUR. AFTER CONSOLE WAS BROUGHT TO (B)(6), THE ISSUE WAS INITIALLY NOT REPRODUCED DURING SEVERAL POWER-CYCLES. THE KBD ASSEMBLY AND ITS RIBBON CABLE WERE VISUALLY INSPECTED, AND NO OBVIOUS SIGNS OF DAMAGE OR DEGRADATION (E.G. CORROSION) WERE OBSERVED. IN THE COURSE OF TROUBLESHOOTING THE CONSOLE WAS SET UP TO POWER-CYCLE 500 TIMES (USING POWER-CYCLING FIXTURE), AFTER WHICH CONSOLE LOGS WERE ANALYZED. ANALYSIS REVEALED 13 OCCURRENCES OF KBD COMMUNICATION ERRORS AND 15 OCCURRENCES OF ALARM #24. AFTER THE 4-IN-1 WAS REPLACED AND TEST REPEATED, OCCURRENCES OF KBD-RELATED ERRORS AND ALARMS WAS REDUCED. THE CAUSE OF THE CONTROLLER ALARM UPON BOOT-UP WAS LOSS OF COMMUNICATION BETWEEN EPC AND KBD, MOST LIKELY DUE TO KBD ASSEMBLY MALFUNCTION. THIS REPORT IS BEING FILED AS PART OF A RETROSPECTIVE REVIEW OF HISTORICAL RECORDS.

    Description of Event or Problem · 0

    THE USER FACILITY'S BIOMEDICAL ENGINEER REPORTED THE AUTOMATED IMPELLA CONTROLLER (AIC) EXPERIENCED A CONTROLLER ERROR YELLOW ALARM. THERE WAS NO PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2039717 AUTOMATED IMPELLA CONTROLLER CONTROL, PUMP SPEED, CARDIOPULMONARY BYPASS OZD ABIOMED, INC. IMPELLA CONTROLLER, PACKAGED, US 1125336 00813502010022

    Patients

    Seq Age Sex Outcome Treatment
    1 0 DA Unknown