BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BLOOD PUMP PU VALVES 15 ML, IN/OUT Ø9 MM

    MDR report key: 17633051 · Received August 28, 2023

    Report

    Report Number
    3004582654-2023-00029
    Event Type
    Injury
    Date Received
    August 28, 2023
    Date of Event
    August 13, 2023
    Report Date
    August 28, 2023
    Manufacturer
    BERLIN HEART GMBH
    Product Code
    DSQ
    UDI-DI
    04260090040157
    PMA / PMN Number
    P160035
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE EXCOR BLOOD PUMP, S/N (B)(6) ON THE PATIENT AT THE TIME OF THE EVENT WAS IN USE FROM (B)(6) 2023 UNTIL (B)(6) 2023 (82 DAYS). WE HAVE REVIEWED THE PRODUCTION RECORDS OF THE EXCOR BLOOD PUMP, S/N (B)(6), THIS PUMP WAS PRODUCED ACCORDING TO OUR SPECIFICATION. ON (B)(6) 2023. THE PUMP WAS CHANGED FOR UPSIZING TO PROVIDE MORE CARDIAC OUTPUT.

    Description of Event or Problem · 0

    BERLIN HEART INC. WAS INFORMED BY THE CLINIC ON (B)(6) 2023 THAT THE PATIENT BEING SUPPORTED WITH AN EXCOR PEDIATRIC VAD SYSTEM HAD ELEVATED LDH LEVEL, 987 ON (B)(6) 2023 AND 1436 ON (B)(6) 2023. THE UPPER LIMIT OF NORMAL FOR THE SITE IS 409. THE SITE REPORTED THAT THE PATIENT DID NOT SHOW ANY CLINICAL SIGNS OF HEMOLYSIS AND THAT THE BILIRUBIN LEVELS WERE STABLE. THE BERLIN HEART EXCOR PUMP FUNCTIONED AS EXPECTED WITH COMPLETE FILLING AND EJECTION, AND NO ABNORMAL NOISES WERE REPORTED FROM THE PUMP. OF NOTE, THE PATIENT WAS TRANSFERRED TO CICU ON (B)(6) 2023 FOR INCREASING RESPIRATORY SUPPORT AND INITIATION OF DIURETICS. STARTED ON MILRINONE DRIP ON (B)(6) 2023 AND EPI DRIP ON (B)(6) 2023. PATIENT WAS INTUBATED ON (B)(6) 2023 DUE TO RESPIRATORY DISTRESS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1316563 BLOOD PUMP PU VALVES 15 ML, IN/OUT Ø9 MM VENTRICULAR ASSIST DEVICE DSQ BERLIN HEART GMBH P15P-001 04260090040157

    Patients

    Seq Age Sex Outcome Treatment
    1 2 YR Female Other