BEUDAMED
    FDA Adverse Event Death Summary report: N

    AUTOMATED IMPELLA CONTROLLER

    MDR report key: 22317717 · Received June 24, 2025

    Report

    Report Number
    1220648-2025-29718
    Event Type
    Death
    Date Received
    June 24, 2025
    Date of Event
    June 19, 2025
    Report Date
    July 15, 2025
    Manufacturer
    ABIOMED, INC.
    Product Code
    OZD
    UDI-DI
    00813502011814
    PMA / PMN Number
    P140003
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE IMPELLA DEVICE WAS NOT RECEIVED FROM THE CUSTOMER. THEREFORE, THE INVESTIGATION OF THE DEVICE WAS NOT POSSIBLE. SHOULD THE DEVICE OR ANY NEW INFORMATION BE RECEIVED, A SUPPLEMENTAL MANUFACTURER DEVICE REPORT WILL BE FILED.

    Additional Manufacturer Narrative · 0

    DEVICE RETURNED ON JUL-14-2025 AND A DEVICE EVALUATION IS UNDERWAY. SHOULD ANY NEW/RELEVANT INFORMATION BECOME AVAILABLE, WE WILL UPDATE THE RECORD B1 ADVERSE EVENT WAS INADVERTENTLY OMITTED ON THE INITIAL MANUFACTURER DEVICE REPORT NUMBER 1220648-2025-29718. B2 DEATH AND DATE OF DEATH WAS INADVERTENTLY OMITTED ON THE INITIAL MANUFACTURER DEVICE REPORT NUMBER 1220648-2025-29718. B5 PATIENT OUTCOME WAS INADVERTENTLY OMITTED ON THE INITIAL MANUFACTURER DEVICE REPORT NUMBER 1220648-2025-29718. H1 TYPE OF REPORT WAS ERRONEOUSLY SELECTED ON THE INITIAL MANUFACTURER DEVICE REPORT NUMBER 1220648-2025-29718. H6 HEALTH EFFECT - CLINICAL CODE 4582 WAS ERRONEOUSLY ENTERED ON THE INITIAL MANUFACTURER DEVICE REPORT NUMBER 1220648-2025-29718. H6 HEALTH EFFECT - IMPACT CODE 1802 WAS INADVERTENTLY OMITTED ON THE INITIAL MANUFACTURER DEVICE REPORT NUMBER 1220648-2025-29718.

    Description of Event or Problem · 0

    THE USER FACILITY REPORTED THE AUTOMATED IMPELLA CONTROLLER (AIC) HAD A "CONTROLLER ERROR ALARM (YELLOW)" ALARM SOUNDED TEMPORARILY AFTER USING THE IMPELLA AND WHILE RETURNING TO THE INTENSIVE CARE UNIT. THE POSITION WAVEFORM DISPLAY DISAPPEARED. EVEN AFTER TAKING MEASURES SUCH AS RE-INSERTING THE CONNECTION CABLE, THE ALARM CONTINUED TO APPEAR FREQUENTLY. THE AIC WAS REPLACED. THE PATIENT'S VITAL SIGNS REMAINED STABLE DURING REPLACMENT.

    Description of Event or Problem · 0

    THE PATIENT EXPIRED DUE TO PREEXISTING CARDIAC CONDITION AND MULTIPLE ORGAN FAILURE. HOWEVER, IT IS UNCLEAR IF THE AUTOMATED IMPELLA CONTROLLER (AIC) ISSUE CONTRIBUTED TO THE CAUSE OF DEATH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1998100 AUTOMATED IMPELLA CONTROLLER TEMPORARY NON-ROLLER TYPE LEFT HEART SUPPORT BLOOD PUMP OZD ABIOMED, INC. AUTOMATED IMPELLA CONTROLLER 1604236 00813502011814

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR Male Death