BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IMPELLA 5.5

    MDR report key: 20332423 · Received September 30, 2024

    Report

    Report Number
    1220648-2024-18744
    Event Type
    Malfunction
    Date Received
    September 30, 2024
    Date of Event
    August 18, 2024
    Report Date
    November 18, 2024
    Manufacturer
    ABIOMED, INC.
    Product Code
    OZD
    UDI-DI
    00813502011630
    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 INVESTIGATION FOR THE PURGE LEAK- PUMP AND PURGE LEAK-CASSETTE HAS BEEN COMPLETED. THE PURGE CASSETTE WAS RETURNED AND EVALUATED. THE PURGE CASSETTE WAS DE-AIRED AND CONNECTED TO A TEST PUMP. PURGE FLOW WAS ~18 ML/HR AND PURGE PRESSURE WAS ~350-450 MMHG. A WINDOW WAS CUT INTO THE CASSETTE NEAR THE PISTON. A LEAK WAS OBSERVED FROM THE PISTON SEAL. THE ROOT CAUSE OF THE PURGE CASSETTE LEAK WAS A PISTON FAILURE. THE PART NUMBER FOR THE PURGE CASSETTE WAS UPDATED FROM 2000163 TO 0043-3011 BECAUSE THE RETURNED PRODUCT (ASSOCIATED WITH THE COMPLAINT PUMP SET) WAS A GEN 1 CASSETTE. THE PUMP WAS NOT RETURNED. THE ROOT CAUSE OF THE PUMP PURGE LEAK WAS DUE TO USE-RELATED SIDEARM FILTER DAMAGE.

    Additional Manufacturer Narrative · 0

    THE PURGE CASSETTE WAS RECEIVED, BUT THE PUMP WAS NOT. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL MDR WILL BE FILED.

    Description of Event or Problem · 0

    THE COMPLAINANT REPORTED THE PATIENT WAS ON IMPELLA 5.5 SUPPORT. IT WAS REPORTED THAT THE PATIENT DROPPED OUT FROM THE BED AND BECAUSE THAT, THE PURGE FILTER BROKE. THE PUMP WAS EXPLANTED THE SAME DAY. IT WAS NOTED THAT THE PATIENT DID WELL AND THE PROCEDURAL OUTCOME WAS THE PATIENT SURVIVED SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2607997 IMPELLA 5.5 TEMPORARY NON-ROLLER TYPE LEFT HEART SUPPORT BLOOD PUMP OZD ABIOMED, INC. IMPELLA 5.5 2025509348 00813502011630

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Male