BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BLOOD PUMP PU VALVES 30 ML, IN/OUT Ø9 MM

    MDR report key: 18880014 · Received March 11, 2024

    Report

    Report Number
    3004582654-2024-00015
    Event Type
    Injury
    Date Received
    March 11, 2024
    Date of Event
    February 25, 2024
    Report Date
    April 19, 2024
    Manufacturer
    BERLIN HEART GMBH
    Product Code
    DSQ
    UDI-DI
    04260090040126
    PMA / PMN Number
    P160035
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, 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 SINCE (B)(6) 2024 UNTIL THE TIME OF THE EVENT ON 2024-02-25 (16 DAYS) WE HAVE REVIEWED THE PRODUCTION RECORDS OF THE EXCOR BLOOD PUMP S/N (B)(6) . 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

    THE EXCOR BLOOD PUMP, S/N (B)(6), WAS IN USE ON THE PATIENT UNTIL THE PUMP EXCHANGE (16 DAYS). ON 2024-03-13 THE BLOOD PUMP IN QUESTION WAS RETURNED TO BERLIN HEART GMBH FOR INVESTIGATION. WE HAVE REVIEWED THE PRODUCTION RECORDS OF THE EXCOR BLOOD PUMP S/N (B)(6). THIS PUMP WAS PRODUCED ACCORDING TO OUR SPECIFICATIONS. DURING INITIAL VISUAL INSPECTION OF THE RETURNED BLOOD PUMP, NO ABNORMALITIES WERE FOUND. THE BLOOD PUMP WAS TESTED FOR FUNCTIONAL PERFORMANCE AS WELL AS NOISE EMISSION. THE PUMP PERFORMANCE MET OUR SPECIFICATIONS. THE BLOOD PUMP WAS COMPLETELY FILLING AND EMPTYING, AND THE MEMBRANE MOVEMENT SHOWED NO ABNORMALITIES. OPERATING NOISES COULD BE HEARD DURING THE TEST. THE NOISES COULD NOT BE ASSESSED AS CRUNCHING. THE COMPLAINT COULD NOT BE CONFIRMED. FOR FURTHER EVALUATION, THE BLOOD PUMP WAS DISASSEMBLED, AND INDIVIDUAL MEMBRANE LAYERS WERE INDIVIDUALLY TESTED. ALL THREE LAYERS OF THE MEMBRANE WERE INTACT AND THE GRAPHITE DISTRIBUTION WAS UNIFORM WITHOUT ANY GAPS. THE STABILIZING RING WAS WITHOUT ANY DEFECTS. NO VIBRATION OF THE VALVE LEAFLETS WAS DETECTED. NO CRUNCHING NOISES WERE DETECTED DURING TESTING. THEREFORE, NO CORRELATION BETWEEN THE PUMP AND INCREASED HEMOLYSIS VALUES OF THE PATIENT COULD BE DETECTED. NEITHER A DEFECT NOR A MALFUNCTION COULD NOT BE DETECTED. ALL EXAMINATIONS REVEALED NO ABNORMALITIES. THE BLOOD PUMP MET ITS SPECIFICATIONS.

    Description of Event or Problem · 0

    THE SITE NOTIFIED BERLIN HEART INC. CLINICAL AFFAIRS THAT A PUMP CHANGE HAD OCCURRED ON A PATIENT BEING SUPPORTED WITH THE EXCOR PEDIATRIC VAD SYSTEM DUE TO AN AUDIBLE "CRUNCHING" NOISE. ADDITIONAL INFORMATION PROVIDED BY THE SITE, ON (B)(6) 2024, REPORTED THAT THE PATIENT WAS EXHIBITED LDH LAB VALUES CONSISTENT WITH HEMOLYSIS. THE PATIENT'S LDH LEVEL INCREASED FROM 508 ON (B)(6) 2024 TO 1200 ON (B)(6) 2024 . ACCORDING TO THE SITE, THE BLOOD PUMP MAINTAINED COMPLETE FILLING AND EJECTION THROUGHOUT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2077260 BLOOD PUMP PU VALVES 30 ML, IN/OUT Ø9 MM VENTRICULAR ASSIST DEVICE DSQ BERLIN HEART GMBH P30P-001 04260090040126

    Patients

    Seq Age Sex Outcome Treatment
    1 24 MO Male Other