BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AUTOMATED IMPELLA CONTROLLER (AIC)

    MDR report key: 17913284 · Received October 11, 2023

    Report

    Report Number
    1220648-2023-03987
    Event Type
    Malfunction
    Date Received
    October 11, 2023
    Date of Event
    September 11, 2023
    Report Date
    June 30, 2025
    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 AUTOMATED IMPELLA CONTROLLER (AIC) CONTROLLER WAS RECEIVED FOR EVALUATION. UPON INVESTIGATION COMPLETION, A SUPPLEMENTAL MDR WILL BE FILED.

    Additional Manufacturer Narrative · 0

    THE INVESTIGATION OF AUTOMATED IMPELLA CONTROLLER (AIC) - CONTROLLER FAILURE (RED ALARM) HAS BEEN COMPLETED. DATA ANALYSIS: THE LOGS CONFIRM MULTIPLE ISSUANCES OF THE CONTROLLER FAILURE (PUD SW CORRUPTION) ALARM; DEVICE ANALYSIS: THE FAILURE WAS REPRODUCED IN THE LAB. EXTRACTION OF THE PUD FIRMWARE REVEALED THAT IT HAD BEEN CORRUPTED. REPLACING THE PUD RESOLVED THE ISSUE. CONCLUSION: THE CONSOLE WAS CONFIRMED FOR THE REPORTED AIC - CONTROLLER FAILURE (RED ALARM). THE ROOT CAUSE OF THE CONTROLLER FAILURE ALARM WAS DUE TO PUD FW CORRUPTION. THE CAUSE OF THE PUD FW CORRUPTION WAS NOT DETERMINED. D2 REVISED COMMON DEVICE NAME SINCE THE INITIAL MANUFACTURER DEVICE REPORT NUMBER 1220648-2023-03987 WAS SUBMITTED IN ACCORDANCE WITH UPDATED PROCEDURES. G1 REPORTING CONTACT EMAIL REVISED ON MANUFACTURER DEVICE REPORT 1220648-2023-03987 IN ACCORDANCE WITH UPDATED PROCEDURES.

    Description of Event or Problem · 0

    A PATIENT OF UNKNOWN AGE AND GENDER RECEIVED HEMODYNAMIC SUPPORT FROM AN IMPELLA CP SMARTASSIST HEART PUMP DUE TO ACUTE MYOCARDIAL INFARCTION/CARDIOGENIC SHOCK. OVER A PERIOD OF SEVERAL HOURS, THE AUTOMATED IMPELLA CONTROLLER DISPLAYED SEVERAL SHORT ¿CONTROLLER ERROR¿ ALARMS. THE USERS DECIDED AGAINST USING THE BACKUP CONTROLLER BECAUSE REMOVAL OF THE IMPELLA HEART PUMP WAS ALREADY PLANNED. THE PATIENT WAS SUCCESSFULLY WEANED FROM IMPELLA SUPPORT AND SUFFERED NO HARM FROM THE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2067675 AUTOMATED IMPELLA CONTROLLER (AIC) TEMPORARY NON-ROLLER TYPE LEFT HEART SUPPORT BLOOD PUMP OZD ABIOMED, INC. AUTOMATED IMPELLA CONTROLLER (AIC) 1130671 00813502011289

    Patients

    Seq Age Sex Outcome Treatment
    1 0 DA Unknown