BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AUTOMATED IMPELLA CONTROLLER

    MDR report key: 19637843 · Received June 28, 2024

    Report

    Report Number
    1220648-2024-12791
    Event Type
    Malfunction
    Date Received
    June 28, 2024
    Date of Event
    June 22, 2024
    Report Date
    October 1, 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
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE IMPELLA 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.

    Additional Manufacturer Narrative · 0

    THE INVESTIGATION FOR THE CONSOLE (AIC) SHUTDOWN HAS BEEN COMPLETED. DATA LOGS WERE REVIEWED WHICH SHOWED THE FIRST COMPLAINT OCCURRED WHEN THE IO-GRAPHICS PROCESS CRASHED. IMMEDIATELY AFTER, THE CONSOLE REBOOTED IN RESPONSE FOLLOWED BY AN IO-GRAPHICS CORE DUMP AND AN UNEXPECTED SHUTDOWN ALARM CONFIRMING WHAT WAS REPORTED CLINICALLY. THERAPY WAS RESUMED BEFORE THE PUMP WAS UNPLUGGED AND MOVED OVER TO (B)(6). THE SECOND FAILURE WAS AN UNRELIABLE PLACEMENT SIGNAL ALARM THAT CONTINUED THROUGH THE END OF THE CASE. THE LT LOGS SHOW THAT THE PLACEMENT SIGNAL DECLINES OVER 100 MMHG BEFORE JUMPING TO 3000MMHG TRIGGERING THE UNRELIABLE PLACEMENT SIGNAL ALARM. CONSOLE WITH SERIAL NUMBER (B)(6) WAS RETURNED FOR INVESTIGATION WHICH WAS THE INCORRECT CONSOLE. (B)(6) DOES NOT NEED TO BE RETURNED AS THIS IS A 3RD PARTY SOFTWARE FAILURE THAT IS UNLIKELY TO REPRODUCE. (B)(6) ALSO DOES NOT NEED TO BE RETURNED AS THE FAILURE WAS CAUSED BY PUMP DEGRADATION. THE CAUSE OF THE UNEXPECTED REBOOT WAS THE 3RD PARTY HARDWARE/SOFTWARE QNX THAT RUNS IO-GRAPHICS. THERE WAS NO ISSUE FOUND DURING THE CASE. THE DEVICE FUNCTIONED/OPERATED TO SPECIFICATION. ADDED-D9 DEVICE RETURN DATE, H6 IMPACT CODE 4629.

    Description of Event or Problem · 0

    THE USER FACILITY REPORTED A 60-YEAR-OLD MALE PATIENT WITH CARDIOMYOPATHY WAS IMPLANTED WITH AN IMPELLA 5.5 DEVICE FOR MECHANICAL CIRCULATORY SUPPORT. IT WAS REPORTED THAT AUTOMATED IMPELLA CONTROLLER (AIC) HAD AN UNEXPECTED SHUTDOWN. THE AIC SHUTDOWN AND RESTARTED WITH NO INTERACTION FROM STAFF. THE AIC WAS EXCHANGED. NO PATIENT HARM WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2292900 AUTOMATED IMPELLA CONTROLLER CONTROL, PUMP SPEED, CARDIOPULMONARY BYPASS OZD ABIOMED, INC AUTOMATED IMPELLA CONTROLLER 1769928 00813502011401

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Male