BEUDAMED
    FDA Adverse Event Injury Summary report: N

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

    MDR report key: 14829512 · Received June 27, 2022

    Report

    Report Number
    3004582654-2022-00029
    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
    PMA / PMN Number
    P160035
    Adverse Event
    Yes
    Report Source
    Manufacturer 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.

    Additional Manufacturer Narrative · 0

    NO ABNORMALITIES WERE OBSERVED UPON INITIAL EXAMINATION OF THE RETURNED PUMP. THE BLOOD PUMP WAS THEN TESTED FOR FUNCTIONAL PERFORMANCE USING THE DRIVING UNIT SETTINGS REPORTED BY THE SITE AT THE TIME OF THE EVENT. THE FUNCTIONAL TEST WAS THEN REPEATED USING DIFFERENT PARAMETERS DEFINED IN INTERNAL PROCEDURES. THE PUMP PERFORMANCE WAS WITHIN SPECIFICATION FOR BOTH THE TESTING PARAMETERS DEFINED BY BERLIN HEART AND THE CLINIC'S SETTINGS. THE PUMP SHOWED COMPLETE FILL AND EJECTION. UPON REVIEW OF THE PRODUCTION RECORDS, IT WAS NOTED THAT THE VALVES SHOWED NO ABNORMALITIES DURING TESTING. THE VALVES FUNCTIONED ACCORDING TO SPECIFICATION BOTH DURING PRODUCTION TESTING, AS WELL AS DURING THE FUNCTIONAL TEST FOR THIS ANALYSIS. NO VIBRATION OF THE VALVE LEAFLETS WAS DETECTED. NO INTERMITTENT NOISES WERE DETECTED AT THE OUTLET VALVE DURING TESTING. THEREFORE, NO CORRELATION BETWEEN THE PUMP AND INCREASED HEMOLYSIS VALUES OF THE PATIENT COULD BE DETERMINED.

    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) 2022 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
    2044493 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