BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AUTOMATED IMPELLA CONTROLLER

    MDR report key: 20627325 · Received November 7, 2024

    Report

    Report Number
    1220648-2024-22306
    Event Type
    Malfunction
    Date Received
    November 7, 2024
    Date of Event
    June 11, 2021
    Report Date
    November 6, 2024
    Manufacturer
    ABIOMED, INC.
    Product Code
    OZD
    UDI-DI
    00813502011289
    PMA / PMN Number
    P140003
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE INVESTIGATION FOR THE REPORTED CONTROLLER FAILURE ISSUE HAS BEEN COMPLETED. THE PRODUCT WAS RETURNED (UNK DATE OF RETURN), AND THE ISSUE WAS CONFIRMED. CONSOLE LOGS FROM THE REPORTED DAY OF EVENT ARE CONSISTENT WITH COMPLAINT AND SHOW MULTIPLE KBD COMMUNICATION ERRORS (COMMUNICATION ERROR, CORRUPT REGISTER), POSSIBLE ESD EVENTS (KBD: HIGH GUARD LEVEL), AND CONTROLLER ERROR ALARMS #24 "LOSS OF COMMUNICATION WITH KBD". AFTER CONSOLE WAS SEND TO AACHEN FS, IT WAS TESTED BUT ISSUE WAS NOT REPRODUCED. INSPECTION OF THE CONSOLE - AND SPECIFICALLY KBD ASSEMBLY AND CABLE, DID NOT REVEAL ANY ANOMALIES, DEFECTS, OR EVIDENCE OF CORROSION OR FLUID INGRESS. PER THE RESULTS OF THE CLINICAL REVIEW AND INVESTIGATION, THE ROOT CAUSE OF THE CONTROLLER ALARM WAS CORRUPT COMMUNICATION BETWEEN 4-IN-1 AND KBD, MOST LIKELY DUE TO 4-IN-1 CARRIER MALFUNCTION. THIS REPORT IS BEING FILED AS PART OF A RETROSPECTIVE REVIEW OF HISTORICAL RECORDS.

    Description of Event or Problem · 0

    THE USER FACILITY REPORTED A PATIENT IN ACUTE MYOCARDIAL INFARCTION/CARDIOGENIC SHOCK ON AN AUTOMATED IMPELLA CONTROLLER (AIC) FOR MECHANICAL CIRCULATORY SUPPORT. WHILE ON SUPPORT, THE AIC EXPERIENCED A CONTROLLER FAILURE RED ALARM. IT WAS RECOMMENDED TO THE PHYSICIAN TO SWITCH TO ANOTHER AIC. THE PHYSICIAN DECIDED TO EXPLANT THE IMPELLA INSTEAD. THERE WAS NO REPORT OF PATIENT HARM OR INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2132403 AUTOMATED IMPELLA CONTROLLER CONTROL, PUMP SPEED, CARDIOPULMONARY BYPASS OZD ABIOMED, INC. AUTOMATED IMPELLA CONTROLLER 1133541 00813502011289

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Female