BEUDAMED
    FDA Adverse Event Injury Summary report: N

    IMPELLA 5.5

    MDR report key: 17410977 · Received July 27, 2023

    Report

    Report Number
    1220648-2023-02547
    Event Type
    Injury
    Date Received
    July 27, 2023
    Date of Event
    July 3, 2023
    Report Date
    September 11, 2023
    Manufacturer
    ABIOMED, INC.
    Product Code
    OZD
    UDI-DI
    00813502012828
    PMA / PMN Number
    P140003
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AR, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE INVESTIGATION INTO THE PUMP STOP ISSUE HAS BEEN COMPLETED SINCE THE ORIGINAL REPORT WAS FILED. THE MEDICAL CENTER RETURNED THE IMPELLA DEVICE AND DATA LOGS FOR ANALYSIS. THE ROOT CAUSE OF THE PUMP STOP ISSUE WAS AN OPEN ELECTRICAL LINE WITH ALL THREE-MOTOR PHASE LINE FOUND TO BE OPEN IN RED HANDLE. THE DATA LOGS ALSO NOTED THE ABRUPT OCCURRENCE OF THE MOTOR CURRENT SPIKE AND PUMP STOP. THE FAILURE MODE WILL BE MONITORED AND TRENDED.

    Additional Manufacturer Narrative · 0

    THE IMPELLA DEVICE WAS NOT RECEIVED FROM THE CUSTOMER AND THEREFORE, AN EVALUATION OF THE DEVICE WAS NOT POSSIBLE. UPON INVESTIGATION CLOSURE, A SUPPLEMENTAL MDR WILL BE FILED. INSTRUCTIONS FOR USE FOR THE RELATED EVENT ARE AS FOLLOWS: ¿MAINTAINING ACT AT OR ABOVE 250 SECONDS WILL HELP PREVENT A THROMBUS FROM ENTERING THE CATHETER AND CAUSING A SUDDEN STOP ON STARTUP.¿ ¿UNRESOLVED PURGE PRESSURE HIGH ALARM IF NOT RESOLVED BY THE RECOMMENDATIONS PROVIDED, HIGH PURGE PRESSURE¿WHICH TRIGGERS THE ¿PURGE PRESSURE HIGH¿ ALARM MESSAGE¿COULD BE AN INDICATION OF A KINK IN THE IMPELLA CATHETER. IN THIS CASE, THE MOTOR IS NO LONGER BEING PURGED AND MAY EVENTUALLY STOP.¿ ¿IMPELLA STOPPED IF THE IMPELLA CATHETER HAS STOPPED SUDDENLY: 1. TRY TO RESTART THE CATHETER AT PREVIOUS P-LEVEL. 2. IF THE IMPELLA DOES NOT RESTART, TRY TO RESTART AT P-2. 3. IF THE IMPELLA DOES NOT RESTART OR STOPS AGAIN, WAIT 1 MINUTE AND TRY TO RESTART AGAIN. 4. IF THE IMPELLA RESTARTS, WEAN DOWN TO P-2 AS THE PATIENT CAN TOLERATE. UNDER THESE CIRCUMSTANCES, CATHETER FUNCTION IS NOT RELIABLE AND THE IMPELLA MAY STOP AGAIN. 5. IF THE IMPELLA DOES NOT RESTART, REMOVE THE IMPELLA FROM THE VENTRICLE AS SOON AS POSSIBLE TO AVOID AORTIC INSUFFICIENCY.¿

    Description of Event or Problem · 0

    THE USER FACILITY REPORTED A 52-YEAR-OLD MALE WITH HEART FAILURE WAS IMPLANTED WITH AN IMPELLA 5.5 DEVICE FOR MECHANICAL CIRCULATORY SUPPORT. ON DAY 26 OF SUPPORT, THE PUMP STOPPED AFTER THEY WHERE GETTING PATIENT FROM COMMODE TO CHAIR. THEY TRIED TO RESTART AND KEPT GETTING CONTROLLER FAILURE ALARM. THE FIELD SERVICE REPRESENTATIVE HAD THEM TRY NEW AUTOMATED IMPELLA CONTROLLER WITH NO RESOLUTION. PATIENT HAD TO BE TAKEN TO OR FOR UNPLANNED IMPELLA 5.5 PUMP EXCHANGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1968266 IMPELLA 5.5 TEMPORARY NON-ROLLER TYPE LEFT HEART SUPPORT BLOOD PUMP OZD ABIOMED, INC. IMPELLA 5.5 2024315412 00813502012828

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR Male