BEUDAMED
    FDA Adverse Event Injury Summary report: N

    IMPELLA :LP5.0

    MDR report key: 8075282 · Received November 15, 2018

    Report

    Report Number
    1220648-2018-00147
    Event Type
    Injury
    Date Received
    November 15, 2018
    Date of Event
    July 11, 2018
    Report Date
    October 19, 2018
    Manufacturer
    ABIOMED EUROPE GMBH
    Product Code
    OZD
    PMA / PMN Number
    P140003
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    AN EVALUATION OF THE DEVICE COULD NOT BE PERFORMED AS THE IMPELLA LP5.0 WAS NOT RETURNED TO THE MANUFACTURE AS IT WAS DISCARDED FOLLOWING USE. A REVIEW OF THE DEVICE HISTORY RECORD DID NOT REVEAL ANY ISSUES WITH THE PUMP DURING MANUFACTURE. THERE WERE NO OTHER COMPLAINTS REPORTED FOR OTHER PUMPS IN THIS LOT. THE ROOT CAUSE OF THE BLOOD LOSS WAS UNABLE TO BE DETERMINED AS THE PRODUCT WAS NOT RETURNED AND FURTHER CLINICAL INFORMATION WAS NOT PROVIDED. THERE WAS NO MALFUNCTION OF THE DEVICE THAT WE ARE AWARE MAY HAVE OCCURRED.

    Description of Event or Problem · 1

    THE IMPELLA LP5.0 WAS PLACED IN THE PATIENT ON (B)(6) 2018. AN ECMO WAS ALSO PLACED IN THE PATIENT, AND THE IMPELLA AND AN ECMO WERE USED IN COMBINATION TO TREAT THE PATIENT'S LOW CARDIAC OUTPUT. THE PATIENT WAS DIAGNOSED WITH DISSEMINATED INTRAVASCULAR COAGULATION (DIC), AND IT WAS REPORTED THAT THE PATIENT'S CONDITION WAS COMPLICATED BY A DETERIORATION OF HIS GENERAL CONDITION. THE PATIENT DID REQUIRE A MASS BLOOD TRANSFUSION IN RESPONSE TO HEMORRHAGE AND HEMOLYSIS AS A RESULT OF THE DIC. DURING PATIENT SUPPORT THE DIC IMPROVED AND THE PATIENT'S HEMODYNAMICS BECAME STABLE. THE IMPELLA LP5.0 WAS REMOVED FROM THE PATIENT ON (B)(6) 2018 AFTER 220 HOURS OF SUCCESSFUL PATIENT SUPPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    916003 IMPELLA :LP5.0 TEMPORARY NON-ROLLER TYPE LEFT HEART SUPPORT BLOOD PUMP. OZD ABIOMED EUROPE GMBH IMPELLA LP5.0 1331370

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Required Intervention ECMO (EXTRACORPOREAL MEMBRANE OXYGENATION)