BEUDAMED
    FDA Adverse Event Death Summary report: N

    AUTOMATED IMPELLA CONTROLLER

    MDR report key: 20007360 · Received August 20, 2024

    Report

    Report Number
    1220648-2024-15881
    Event Type
    Death
    Date Received
    August 20, 2024
    Date of Event
    February 8, 2023
    Report Date
    November 8, 2024
    Manufacturer
    ABIOMED, INC.
    Product Code
    OZD
    UDI-DI
    00813502010022
    PMA / PMN Number
    P140003
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THIS FILE IS BEING SUBMITTED AS PART OF A RETROSPECTIVE REVIEW OF HISTORICAL RECORDS AFTER WHICH MEDICAL SAFETY HAS UPDATED THE REPORT TYPE. CORRECTED INFORMATION FOR THE INITIAL MFR 1220648-2024-15881 WAS PROVIDED IN SECTIONS B1, B2, B5, H1, AND H6.

    Additional Manufacturer Narrative · 0

    THE IMPELLA DEVICE WAS RECEIVED FROM THE CUSTOMER ON (B)(6)2023. DATA REVIEW: IMC LOGS FROM THE COMPLAINT DATE REVEALED THAT THE CONSOLE ISSUED THE PURGE DISC NOT DETECTED ALARM (EVENT SET #402) SEVERAL TIMES THROUGH A LONG TIME. RE-INSERTION OF PC/ PURGE DISC WAS OBSERVED, YET THE CONSOLE STILL HAD PROBLEM IN DETECTING PURGE DISC. DEVICE ANALYSIS: THE CONSOLE WAS TESTED AFTER ARRIVING IN DANVERS. THE ISSUE WITH PROPERLY DETECTING THE PURGE PRESSURE DISC WAS REPRODUCED, AND PURGE FLAG WAS CONFIRMED TO BE BROKEN (MISSING AT BLUE DISC RETAINER). BEFORE RETURNING THIS CONSOLE BACK TO THE CUSTOMER, FS WAS INSTRUCTED TO REPLACE THE PURGE FLAG AND RETAINER, CLEAN THE PURGE ASSEMBLY, AND PERFORM PREVENTIVE MAINTENANCE SECTION 10-12 (0042-7309) AND FUNCTIONAL CHECK ON CONSOLE AND OPTICAL SYSTEM (0042-7316).

    Description of Event or Problem · 0

    ADDITIONAL INFORMATION NOTED THAT THE CARE WAS WITHDRAWN AND THE PATIENT EXPIRED. MEDICAL SAFETY REVIEW OF THE EVENT NOTED THERE IS NOT ENOUGH INFORMATION TO EXCLUDE THE IMPELLA DEVICE AS AN ASSOCIATED FACTOR IN THE PATIENT'S DEMISE.

    Description of Event or Problem · 0

    THE COMPLAINANT REPORTED THAT THEIR AIC (AUTOMATED IMPELLA CONTROLLER) FAILED TO RECOGNIZE AN INSTALLED PURGE DISC DURING A PURGE CASSETTE SWAP. A SECOND PURGE CASSETTE WAS INSTALLED FOLLOWING THE FAILURE, HOWEVER THE ISSUE REMAINED. THE AIC WAS SUBSEQUENTLY SWAPPED AND PATIENT SUPPORT CONTINUED WITHOUT FURTHER ISSUE. THERE WAS NO PATIENT HARM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1045756 AUTOMATED IMPELLA CONTROLLER CONTROL, PUMP SPEED, CARDIOPULMONARY BYPASS OZD ABIOMED, INC. IMPELLA CONTROLLER, PACKAGED, US 1143527 00813502010022

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Male Death