BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BLOOD PUMP PU VALVES 15 ML, IN/OUT 9 MM

    MDR report key: 11802086 · Received May 10, 2021

    Report

    Report Number
    3004582654-2021-00026
    Event Type
    Injury
    Date Received
    May 10, 2021
    Date of Event
    April 18, 2021
    Report Date
    May 10, 2021
    Manufacturer
    BERLIN HEART GMBH
    Product Code
    DSQ
    UDI-DI
    04260090040157
    PMA / PMN Number
    P160035
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    IN B3, THE DATE OF EVENT IS (B)(6) 2021, NOT (B)(6) 2021. IN D4, THE EXPIRATION DATE IS 4/30/2023. NOT 4/30/2021.

    Additional Manufacturer Narrative · 1

    THE PUMP, 2020297, WAS IN USE FROM (B)(6) 2021 TO (B)(6) 2021 (4 DAYS). AS OF (B)(6) 2021, THE PATIENT CONTINUES TO HAVE HEMOLYSIS AND THE PATIENT WAS UPSIZED TO A P25P-001 PUMP.

    Description of Event or Problem · 1

    BERLIN HEART WAS INFORMED BY THE SITE ON (B)(6) 2021 THAT A PATIENT BEING SUPPORTED WITH THE EXCOR PEDIATRIC VAD SYSTEM IN THE LVAD CONFIGURATION HAD DEVELOPED HEMOLYSIS. THE PUMP WAS COMPLETELY FILLING AND EJECTING. BASED ON LDH VALUES RECEIVED BY BERLIN HEART FROM THE SITE ON (B)(6) 2021 AND (B)(6) 2021, IT WAS DETERMINED THAT THE HEMOLYSIS WAS A REPORTABLE ADVERSE EVENT. ON BOTH DAYS THE PATIENT'S LDH LEVEL WAS GREATER THAN 2700 WHICH EXCEEDS 2.5 TIMES THE NORMAL RANGE FOR THIS SITE. OF NOTE, THE PLASMA FREE HEMOGLOBIN WAS GREATER THAN 2300 AND GREATER THAN 1000. ON (B)(6) 2021 THE SITE EXCHANGED THE EXCOR BLOOD PUMP. ON (B)(6) 2021, THE LDH REMAINED GREATER THAN 2700 AND THE PLASMA FREE HEMOGLOBIN WAS GREATER THAN 1000.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    697508 BLOOD PUMP PU VALVES 15 ML, IN/OUT 9 MM VENTRICULAR ASSIST DEVICE DSQ BERLIN HEART GMBH P15P-001 04260090040157

    Patients

    Seq Age Sex Outcome Treatment
    1 20 MO Other