BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IMPELLA 5.5

    MDR report key: 17649593 · Received August 30, 2023

    Report

    Report Number
    1220648-2023-02900
    Event Type
    Malfunction
    Date Received
    August 30, 2023
    Date of Event
    August 20, 2021
    Report Date
    August 30, 2023
    Manufacturer
    ABIOMED, INC.
    Product Code
    OZD
    UDI-DI
    813502011531
    PMA / PMN Number
    P140003
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE INVESTIGATION INTO THE REPORTED PURGE LEAK AND "FALSE IN AORTA ALARMS" WAS COMPLETED. THE DEVICE WAS RETURNED FOR EVALUATION. A LEAK REPRODUCTION TEST WAS PERFORMED WHICH CONFIRMED A PURGE FLUID LEAK AT THE YELLOW LUER CONNECTION ON THE PURGE SIDEARM. VISUAL INSPECTION OF THE YELLOW LUER REVEALED A CRACK. THE ROOT CAUSE OF THE REPORTED PURGE SIDEARM LEAK WAS DETERMINED TO BE A DAMAGED YELLOW LUER. OF NOTE, SODIUM BICARBONATE WAS USED AS A PURGE SOLUTION. BASED ON THE CLINICAL INFORMATION PROVIDED THAT THE PUMP WAS PROPERLY POSITIONED, THE ROOT CAUSE OF THE FALSE IN AORTA ALARMS WAS MOST LIKELY DUE TO PATIENT CONDITION. THIS REPORT IS BEING FILED AS PART OF A RETROSPECTIVE REVIEW OF HISTORICAL RECORDS. THE FAILURE MODES WILL BE MONITORED AND TRENDED.

    Description of Event or Problem · 0

    THE USER FACILITY REPORTED AN UNKNOWN LEAK IN THE CATHETER NEAR THE SIDE ARM OF A 68-YEAR-OLD, BLACK MALE PATIENT IMPLANTED WITH AN IMPELLA 5.5 FOR MANAGEMENT OF CARDIOMYOPATHY. THE USER FACILITY ADDITIONALLY REPORTED "FALSE IN AORTA ALARMS". PUMP POSITION WAS CONFIRMED VIA ULTRASOUND AND PLACEMENT SIGNAL MONITORING WAS ULTIMATELY DISABLED. NO FURTHER INFORMATION WAS PROVIDED. THERE WERE NO REPORTS OF HARM TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1469610 IMPELLA 5.5 TEMPORARY NON-ROLLER TYPE LEFT HEART SUPPORT BLOOD PUMP OZD ABIOMED, INC. IMPELLA 5.5 2022074272 813502011531

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Male