BEUDAMED
    FDA Adverse Event Injury Summary report: N

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

    MDR report key: 17173204 · Received June 21, 2023

    Report

    Report Number
    3004582654-2023-00022
    Event Type
    Injury
    Date Received
    June 21, 2023
    Date of Event
    June 6, 2023
    Report Date
    June 21, 2023
    Manufacturer
    BERLIN HEART GMBH
    Product Code
    DSQ
    UDI-DI
    04260090040157
    PMA / PMN Number
    P160035
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, 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 (27 DAYS). WE HAVE REVIEWED THE PRODUCTION RECORDS OF THE EXCOR BLOOD PUMP. THIS PUMP WAS PRODUCED ACCORDING TO OUR SPECIFICATION.

    Description of Event or Problem · 0

    BERLIN HEART INC. WAS INFORMED ON JUNE 7TH 2023, THAT ON (B)(6) 2023, THAT CODE STROKE CALLED FOR EYE DEVIATION AND FACIAL PALSY. CTA REASSURING HOWEVER, NEUROLOGIC SEQUELA CONTINUE WITH ANISOCORIA AND DYSCONJUGATE GAZE. LAB VALUES PTT 66.2, PLATELETS 406, FIBRINOGEN 475, INR 1.2, LDH 1913. THROMBUS NOTED IN THE PUMP AT THE LOCATION OF THE VALVES ON THE INFLOW CANNULA AND THE PUMP WAS CHANGED DUE TO THROMBUS ON (B)(6) 2023.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1900219 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 MO Male Life Threatening| O