BEUDAMED
    FDA Adverse Event Injury Summary report: N

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

    MDR report key: 14829521 · Received June 27, 2022

    Report

    Report Number
    3008454189-2022-00009
    Event Type
    Injury
    Date Received
    June 27, 2022
    Date of Event
    June 16, 2022
    Report Date
    June 27, 2022
    Manufacturer
    BERLIN HEART GMBH
    Product Code
    DSQ
    UDI-DI
    04260090040157
    Adverse Event
    Yes
    Report Source
    Distributor report
    Reporter Location
    TX, US
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE EXCOR BLOOD PUMP, S/N, (B)(4) ON THE PATIENT AT THE TIME OF THE EVENT WAS IN USE FROM (B)(6) 2022 UNTIL (B)(6) 2022 (161 DAYS). WE HAVE REVIEWED THE PRODUCTION RECORDS OF THE EXCOR BLOOD PUMP, S/N (B)(4). THIS PUMP WAS PRODUCED ACCORDING TO OUR SPECIFICATION. A DETAILED INVESTIGATION REPORT WILL BE PROVIDED AS SOON AS IT IS AVAILABLE.

    Description of Event or Problem · 0

    BERLIN HEART INC. CLINICAL AFFAIRS WAS NOTIFIED WHILE ON SITE, (B)(6) 2022 THAT, ON (B)(6) 2022, THE PUMP HAD A VIBRATION AND INTERMITTENT NOISE AT THE OUTFLOW VALVE. THE PATIENT HAD AN INCREASED LDH FROM 3383 ON (B)(6) 2022 TO >6000 ON (B)(6) 2022, PLASMA FREE HGB 50 AST 29, ALT 152, (B)(6) 22 INCREASED TO AST 952, ALT 2199, (B)(6) 2022. THE PATIENT REMAINED HEMODYNAMICALLY STABLE THROUGHOUT. THE BERLIN HEART EXCOR PUMP FUNCTIONED AS EXPECTED WITH COMPLETE FILL AND EJECTION, WITH NO DEPOSITS NOTED IN THE PUMP, CANNULAS OR CONNECTING SETS. PUMP CHANGE OCCURRED ON (B)(6) 2022 WITHOUT UNTOWARD EFFECT TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2017917 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 10 MO Male Other