BEUDAMED
    FDA Adverse Event Injury Summary report: N

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

    MDR report key: 16279954 · Received February 1, 2023

    Report

    Report Number
    3008454189-2023-00002
    Event Type
    Injury
    Date Received
    February 1, 2023
    Date of Event
    December 26, 2022
    Report Date
    February 1, 2023
    Manufacturer
    BERLIN HEART GMBH
    Product Code
    DSQ
    UDI-DI
    04260090040157
    Adverse Event
    Yes
    Report Source
    Distributor report
    Reporter Location
    IN, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    EXPIRATION DATE. APPROXIMATE AGE OF THE DEVICE.

    Additional Manufacturer Narrative · 0

    THE PATIENT WAS WITHDRAWN FROM CARE ON (B)(6) 2023 DUE TO MULTI-SYSTEM ORGAN FAILURE. THE PUMP WAS NOT RETURNED TO BHI FOR EVALUATION.

    Description of Event or Problem · 0

    BERLIN HEART INC. WAS INFORMED ON (B)(6) 2022, ABOUT INCREASED LDH AND PLASMA FREE HEMAGLOBIN. THE SITE DID NOT INTERVENE DUE TO COMPLEXITIES OF MEDICAL MANAGEMENT. IT WAS REPORTED THAT THE PATIENT'S LDH IS GRATER THAN 2.5X THE UPPER LIMITS OF NORMAL. PATIENTS LDH INCREASED TO 3593. THE UPPER LIMIT OF NORMAL FOR LDH AT THIS SITE IS 575. 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.

    Description of Event or Problem · 0

    BERLIN HEART INC. WAS INFORMED ON DECEMBER 26TH, 2022, ABOUT INCREASED LDH AND PLASMA FREE HEMAGLOBIN. THE SITE DID NOT INTERVENE DUE TO COMPLEXITIES OF MEDICAL MANAGEMENT. IT WAS REPORTED THAT THE PATIENT'S LDH IS GRATER THAN 2.5X THE UPPER LIMITS OF NORMAL. PATIENTS LDH INCREASED TO 3593. THE UPPER LIMIT OF NORMAL FOR LDH AT THIS SITE IS 575. 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
    733843 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 5 MO Female Other