BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AUTOMATED IMPELLA CONTROLLER

    MDR report key: 18746743 · Received February 21, 2024

    Report

    Report Number
    1220648-2024-06935
    Event Type
    Malfunction
    Date Received
    February 21, 2024
    Date of Event
    February 8, 2024
    Report Date
    May 15, 2024
    Manufacturer
    ABIOMED, INC
    Product Code
    OZD
    PMA / PMN Number
    P140003
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SD, US
    Reporter Occupation
    BIOMEDICAL ENGINEER
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE INVESTIGATION FOR THE REPORTED CONSOLE (AIC) SHUTDOWN HAS BEEN COMPLETED. THE CONSOLE HAS BEEN RETURNED FOR EVALUATION. THE CONSOLE WAS TESTED THE REPORTED FAILURE MODE COULD NOT BE REPRODUCED NATURALLY UPON RUNNING THE PUMP FOR 16 HOURS. NO PROBLEM WAS FOUND WITH THE FLASH CARDS. UPON FORCE SHUTDOWN OF THE IO-GRAPHICS VIA TELNET COMMAND ¿SLAY -S SIGABRT IO-GRAPHICS,¿ THE CONSOLE WAS SHUT DOWN AND REBOOTED AUTOMATICALLY, AS HAPPENED AT THE CUSTOMER SITE. DATA LOGS WERE REVIEWED FINDING THE CONSOLE RECEIVED THE LOG ¿SYSTEMIDLE:PROCESS IO-GRAPHICS 339995 DIED ABNORMALLY.¿ AFTER THAT, THE CONSOLE WAS SHUT DOWN UNEXPECTEDLY IN 18 SECONDS AND REBOOTED AUTOMATICALLY IN 22 SECONDS. DURING BOOTUP FOLLOWING, THE LOG INDICATED ¿IO-GRAPHICS.CORE¿ FILE HAS BEEN DELETED - ¿IMPELLALIB: FOUND CORE DUMP FILE /USERFLASH/IO-GRAPHICS.CORE WITH SIZE : 23281664 AND LAST MODIFIED ON: 2024-02-08, 10:14:18 PM.¿ FOLLOWING THAT, THE CONSOLE RECORDED AN ERROR IN ESTABLISHING COMMUNICATION WITH ¿IMPELLACONNECT_BRIDGE,¿ AS THE SOFTWARE IS DESIGNED TO TURN OFF THE ¿IMPELLACONNECT_BRIDGE¿ COMMUNICATION AFTER AN UNEXPECTED CONSOLE SHUTDOWN. THEN, THE CONSOLE RECEIVED THE UNEXPECTED CONTROLLER SHUTDOWN ¿ ALARM EVENT SET #603, WHICH CONFIRMED THE REPORTED FAILURE MODE. THE ROOT CAUSE OF INTERMITTENT UNEXPECTED CONTROLLER SHUTDOWN WAS MOST LIKELY THE 3RD PARTY HARDWARE/SOFTWARE THAT RUNS IO-GRAPHICS. IN ACCORDANCE WITH UPDATED PROCEDURES, SECTION D2 HAS BEEN REVISED FROM THE INITIAL SUBMISSION.

    Additional Manufacturer Narrative · 0

    THE IMPELLA DEVICE WAS RETURNED AND AN EVALUATION IS UNDERWAY. UPON COMPLETION OF OUR ANALYSIS, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 0

    THE USER FACILITY REPORTED THAT AN UNEXPECTED AUTOMATED IMPELLA CONTROLLER (AIC) SHUTDOWN ALARM CAME ON DURING PATIENT SUPPORT. THE AIC WAS EXCHANGED. THE WAS NO PATIENT HARM REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    62028 AUTOMATED IMPELLA CONTROLLER CONTROL,, PUMP SPEED, CARDIOPULMONARY BYPASS OZD ABIOMED, INC AUTOMATED IMPELLA CONTROLLER 1253203

    Patients

    Seq Age Sex Outcome Treatment
    1 0 DA Unknown