BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AUTOMATED IMPELLA CONTROLLER (AIC)

    MDR report key: 19298199 · Received May 13, 2024

    Report

    Report Number
    1220648-2024-11069
    Event Type
    Malfunction
    Date Received
    May 13, 2024
    Date of Event
    April 27, 2024
    Report Date
    June 11, 2024
    Manufacturer
    ABIOMED, INC.
    Product Code
    OZD
    UDI-DI
    00813502011289
    PMA / PMN Number
    P140003
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE INVESTIGATION FOR THE REPORTED CONSOLE (AIC) YELLOW ALARM HAS BEEN COMPLETED. THE CONSOLE WAS RETURNED FOR EVALUATION. REPORTED CONTROLLER ERROR ALARM WAS IDENTIFIED AS RELATED TO COMMUNICATION ISSUES BETWEEN KBD AND 4-IN-1 CARRIER. THE ISSUE WAS NOT REPRODUCED DURING TESTING BUT WAS MOST LIKELY RELATED TO AN UNDETERMINED MALFUNCTION OF KBD. IT IS MOST LIKELY THAT THE MOMENTARY COMMUNICATION GLITCH ORIGINATED AT THE KBD ASSEMBLY. CONSOLE LOGS FROM THE REPORTED DAY OF EVENT ARE MOSTLY CONSISTENT WITH COMPLAINT AND SHOW A (YELLOW) CONTROLLER ERROR ALARM (#24, DUE TO LOSS OF COMMUNICATION WITH KEYPAD), PRECEDED BY SEVERAL ERROR MESSAGES INDICATING KBD COMMUNICATION ERRORS ¿IMC-KBD ERROR: 0XA2 0X52 0X00¿. THE CAUSE OF THE AIC ISSUE WAS A DEFECTIVE KBD/DISPLAY. ADDED- D6A/D6B.

    Additional Manufacturer Narrative · 0

    THE AUTOMATED IMPELLA CONTROLLER (AIC) 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

    THE COMPLAINANT REPORTED THAT DURING IMPELLA CP SUPPORT, THE 50-YEAR-OLD MALE PATIENT WAS TRANSFERRED TO DIFFERENT HOSPITAL. DURING ECMO INSERTION, THE AUTOMATED IMPELLA CONTROLLER (AIC) DISPLAYED A 'CONTROLLER FAILURE' YELLOW ALARM. THE CONSOLE WAS THEREFORE EXCHANGED AND THE ISSUE RESOLVED. THERE WAS NO REPORTED PATIENT HARM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    410545 AUTOMATED IMPELLA CONTROLLER (AIC) CONTROL,, PUMP SPEED, CARDIOPULMONARY BYPASS OZD ABIOMED, INC. AUTOMATED IMPELLA CONTROLLER (AIC) 1154857 00813502011289

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Male