BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AUTOMATED IMPELLA CONTROLLER

    MDR report key: 20598365 · Received November 4, 2024

    Report

    Report Number
    1220648-2024-21834
    Event Type
    Malfunction
    Date Received
    November 4, 2024
    Date of Event
    November 18, 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
    OH, US
    Reporter Occupation
    BIOMEDICAL ENGINEER
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE INVESTIGATION INTO THE KEYBOARD ROTARY KNOB ISSUE HAS BEEN COMPLETED. THE IMPELLA AUTOMATED CONTROLLER (AIC) WAS RETURNED FOR INVESTIGATION. THE DATA ANALYSIS OF THE LOGS SHOWED THAT UPON PRESSING THE MUTE BUTTON THERE WERE KBD COMMUNICATION ERRORS AND HIGH GUARD AND EVENTUALLY A CONTROLLER ERROR (EVENT SET #24). THESE WERE UNIQUELY PAIRED WITH ERRORS INDICATING BOTH SUBSYSTEMS WERE AFFECTED SIMULTANEOUSLY. THE FAILURE MODE WAS NOT REPRODUCED. THE CABLE/ CONNECTOR MISALIGNMENT WAS NOT OBSERVED BETWEEN THE KEYBOARD (KBD) AND 4-IN-1. ERRORS RELATED TO KBD AND RADIO FREQUENCY IDENTIFICATION (RFID) CAN BE TRIGGERED BY ETERNAL SOURCES OF ELECTROMAGNETIC INTERFERENCE (EMI), BUT NO SUCH LINK COULD BE ESTABLISHED FROM THE EVIDENCE COLLECTED. THE ROOT CAUSE OF THE KBD-RELATED ALARM WAS NOT DETERMINED DUE TO THE INABILITY TO REPRODUCE THE ISSUE. THIS REPORT IS BEING FILED AS PART OF A RETROSPECTIVE REVIEW OF HISTORICAL RECORDS.

    Description of Event or Problem · 0

    THE COMPLAINANT REPORTED THAT THE AUTOMATED IMPELLA CONTROLLER (AIC) SOFT TOUCH BUTTONS WERE NOT FUNCTIONING. THE TEAM WAS DECANNULATING IN THE OPERATING ROOM AND ATTEMPTING TO RAMP UP THE IMPELLA SUPPORT THEN NONE OF THE BUTTONS WOULD RESPOND. THIS AIC WAS REPLACED WITH ANOTHER AIC RESULTING IN THE CONSOLE APPROPRIATELY RAMPING FOR THE IMPELLA 5.5 SUPPORT. THERE WAS NO PATIENT HARM REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    789574 AUTOMATED IMPELLA CONTROLLER CONTROL, PUMP SPEED, CARDIOPULMONARY BYPASS OZD ABIOMED, INC. AUTOMATED IMPELLA CONTROLLER 1651060 00813502011401

    Patients

    Seq Age Sex Outcome Treatment
    1 0 DA Unknown