BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AUTOMATED IMPELLA CONTROLLER

    MDR report key: 20904336 · Received December 11, 2024

    Report

    Report Number
    1220648-2024-24709
    Event Type
    Malfunction
    Date Received
    December 11, 2024
    Date of Event
    February 6, 2023
    Report Date
    December 11, 2024
    Manufacturer
    ABIOMED, INC.
    Product Code
    OZD
    UDI-DI
    00813502011289
    PMA / PMN Number
    P140003
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE INVESTIGATION FOR THE REPORTED ISSUE HAS BEEN COMPLETED. CONSOLE LOGS FROM THE REPORTED DAY OF EVENT ARE CONSISTENT WITH COMPLAINT AND SHOW CONTROLLER ERROR ALARM (DUE TO LOSS OF COMMUNICATION TO KBD) ON TWO CONSECUTIVE BOOT-UPS. THERE¿S ALSO UNUSUALLY HIGH NUMBER OF ERROR MESSAGES SEEMINGLY ASSOCIATED WITH ¿HIGH GUARD LEVEL¿ WHICH, IN NORMAL OPERATING CONDITIONS, IS INDICATIVE OF TOUCH DETECTED OUTSIDE OF THE SOFT-KEY AREA ON THE AIC¿S SCREEN BUT MIGHT ALSO BE EVIDENCE OF EQUIPMENT MALFUNCTION. THERE¿S NO EVIDENCE OF ANY ATTEMPTS TO INITIATE SUPPORT USING (B)(6) ON THAT DAY (NO PUMP CONNECTED, NO PURGE CASSETTE CONNECTED). IT IS UNKNOWN WHETHER THE KBD WAS UNRESPONSIVE AT THAT TIME. AFTER CONSOLE WAS RECEIVED IN AACHEN FS AND TESTED, THE ISSUE HAS NOT BEEN REPRODUCED. INSPECTION OF THE CONSOLE REVEALED SOME MINOR IRREGULARITIES (KINKED INPELLATRONIC CABLE, CONTAMINATED OPTICAL PUMP CONNECTOR) BUT UNRELATED TO THE COMPLAINT OR THE FAILURE MODE. IT¿S BEEN DETERMINED THAT MOST LIKELY COMPONENT CAUSING KBD COMMUNICATION ERRORS WAS THE 4-IN-1 CARRIER, THAT CONTAINS SUB-CIRCUITRY RESPONSIBLE FOR PROCESSING DATA FROM KBD ASSEMBLY. THE CAUSE OF THE AIC ISSUE WAS A DEFECTIVE 4IN1 BOARD. THIS REPORT IS BEING FILED AS PART OF A RETROSPECTIVE REVIEW OF HISTORICAL RECORDS.

    Description of Event or Problem · 0

    THE COMPLAINANT REPORTED AN AUTOMATED IMPELLA CONTROLLER (AIC) ISSUED A CONTROLLER FAILURE ALARM DURING A CLINICAL PROCEDURE. NO INFORMATION WAS PROVIDED ON THE PATIENT INFORMATION, HOWEVER THERE WERE NO ADVERSE EVENTS RELATED TO THE PRODUCT MALFUNCTION REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2433554 AUTOMATED IMPELLA CONTROLLER CONTROL, PUMP SPEED, CARDIOPULMONARY BYPASS OZD ABIOMED, INC. AUTOMATED IMPELLA CONTROLLER 1094049 00813502011289

    Patients

    Seq Age Sex Outcome Treatment
    1 0 DA Unknown