BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BERLIN HEART EXCOR PEDIATRIC VAD

    MDR report key: 10722106 · Received October 22, 2020

    Report

    Report Number
    3004582654-2020-00046
    Event Type
    Injury
    Date Received
    October 22, 2020
    Date of Event
    September 11, 2020
    Report Date
    October 22, 2020
    Manufacturer
    BERLIN HEART GMBH
    Product Code
    DSQ
    UDI-DI
    04260090040157
    PMA / PMN Number
    P160035
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    AT THE TIME OF THE ADVERSE EVENT, THE PUMP WAS FULL FILL AND EJECTION. AFTER THE PUMP CHANGE, THE LDH DROPPED AND AS OF 10/12/2020, THE LDH LEVEL WAS IN THE 600 RANGE AND DROPPING. THE PATIENT IS BACK IN NORMAL RANGE AND HAD NO ADVERSE AFFECTS.

    Description of Event or Problem · 1

    BERLIN HEART WAS INFORMED BY THE SITE ON 9/11/2020 THAT A PATIENT BEING SUPPORTED WITH THE EXCOR PEDIATRIC VAD SYSTEM IN THE LVAD CONFIGURATION HAD EXPERIENCED HEMOLYSIS PRIOR TO A PUMP CHANGE. THE PUMP WAS FULL FILL AND EJECTION. BASED ON LDH VALUES RECEIVED BY BERLIN HEART FROM THE SITE ON 10/12//2020, IT WAS DETERMINED THAT THE HEMOLYSIS WAS REPORTABLE ADVERSE EVENT. PRIOR TO THE PUMP CHANGE, THE PATIENTS LDH WAS GREATER THAN 2.5 TIMES THE NORMAL RANGE OF THE PATIENT AT 1400 THE PLASMA FREE HEMAGLOBIN WAS GREATER THAN 50. AFTER THE PUMP CHANGE, THE LDH DROPPED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1187725 BERLIN HEART EXCOR PEDIATRIC VAD VENTRICULAR ASSIST DEVICE DSQ BERLIN HEART GMBH P15P-001 04260090040157

    Patients

    Seq Age Sex Outcome Treatment
    1 2 YR Other