BEUDAMED
    FDA Adverse Event Injury Summary report: N

    IMPELLA LP 5.0 PUMP

    MDR report key: 8569494 · Received May 1, 2019

    Report

    Report Number
    1220648-2019-00073
    Event Type
    Injury
    Date Received
    May 1, 2019
    Date of Event
    April 3, 2019
    Report Date
    April 3, 2019
    Manufacturer
    ABIOMED, INC.
    Product Code
    OZD
    UDI-DI
    813502011180
    PMA / PMN Number
    P140003
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE IMPELLA LP 5.0 PUMP HAS NOT BEEN RETURNED BY THE CUSTOMER. IF THE PUMP IS RETURNED A FAILURE ANALYSIS INVESTIGATION WILL BE UNDERWAY. A SUPPLEMENTAL MDR WILL BE FILED AT THE COMPLETION OF THE DEVICE'S INVESTIGATION.

    Description of Event or Problem · 1

    THE COMPLAINANT REPORTED A (B)(6) FEMALE CAUCASIAN HAD IMPELLA LP 5.0 PUMP INSERTED. ON (B)(6) 2019, THE PATIENT HAD BLEEDING AT MULTIPLE FEMORAL SITES INCLUDING THE GROIN, AS A RESULTS PRR - 29 WITH INR >2, FRESH FROZEN PLASMA (FFP), VITAMIN K, PLATELETS (PLTS), AND 2 UNITS OF PACKED RED BLOOD CELLS (PRBC) WAS ADMINISTERED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    364336 IMPELLA LP 5.0 PUMP TEMPORARY NON-ROLLER TYPE LEFT HEART SUPPORT BLOOD PUMP, OZD ABIOMED, INC. IMPELLA LP 5.0 PUMP 1387941 813502011180

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Required Intervention