BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BLOOD PUMP PU VALVES 25 ML, IN/OUT Ø9 MM

    MDR report key: 16809463 · Received April 25, 2023

    Report

    Report Number
    3008454189-2023-00006
    Event Type
    Injury
    Date Received
    April 25, 2023
    Date of Event
    March 27, 2023
    Report Date
    April 25, 2023
    Manufacturer
    BERLIN HEART GMBH
    Product Code
    DSQ
    UDI-DI
    04260090040119
    Adverse Event
    Yes
    Report Source
    Distributor report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    HE EXCOR BLOOD PUMP, S/N (B)(6), WAS IN USE ON THE PATIENT SINCE (B)(6) 2023 AND STILL ON THE PATIENT. WE HAVE REVIEWED THE PRODUCTION RECORDS OF THE EXCOR BLOOD PUMP, S/N (B)(6). THIS PUMP WAS PRODUCED ACCORDING TO OUR SPECIFICATION. AS OF 4/20/23, THE PATIENT CONTINUES ON THE EXCOR BLOOD PUMP. NO NEW LABORATORY VALUES HAVE BEEN PROVIDED BY THE SITE.

    Description of Event or Problem · 0

    BERLIN HEART INC. WAS INFORMED ON (B)(6) 2023, THE PATIENT HAD A DROP IN HEMOGLOBIN. LDH LEVELS INCREASED FROM 421 TO 1132 AND PFHGB INCREASED FROM 12.9 TO 32. THE PATIENT TRANSFUSED PRBC IN RESPONSE. THE EXCOR BLOOD PUMP IS PERFORMING AS INTENDED WITH COMPLETE EJECTION AND FILL. THERE ARE NO DEPOSITS NOTED IN THE EXCOR BLOOD PUMP, AND NO ABNORMAL SOUNDS FROM THE PUMP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1187204 BLOOD PUMP PU VALVES 25 ML, IN/OUT Ø9 MM VENTRICULAR ASSIST DEVICE DSQ BERLIN HEART GMBH P25P-001X01 04260090040119

    Patients

    Seq Age Sex Outcome Treatment
    1 20 MO Female Other