BEUDAMED
    FDA Adverse Event Injury Summary report: N

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

    MDR report key: 18940794 · Received March 20, 2024

    Report

    Report Number
    3004582654-2024-00018
    Event Type
    Injury
    Date Received
    March 20, 2024
    Date of Event
    February 28, 2024
    Report Date
    May 13, 2024
    Manufacturer
    BERLIN HEART GMBH
    Product Code
    DSQ
    UDI-DI
    04260090040157
    PMA / PMN Number
    P160035
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE EXCOR BLOOD PUMP, S/N (B)(6), WAS IN USE ON THE PATIENT UNTIL THE PUMP EXCHANGE (8 DAYS). WE HAVE REVIEWED THE PRODUCTION RECORDS OF THE EXCOR BLOOD PUMP S/N (B)(6). THIS PUMP WAS PRODUCED ACCORDING TO OUR SPECIFICATIONS. ON (B)(6) 2018 THE BLOOD PUMP IN QUESTION WAS RETURNED TO BERLIN HEART GMBH FOR INVESTIGATION. DURING EVALUATION, THE REPORTED SQUEAKING NOISES WERE CONFIRMED AND REPRODUCED. DURING OPERATION ON PATIENTS, A SQUEAKING NOISE CAN SOMETIMES OCCUR ON THE PU VALVES. FURTHER ANALYSIS INDICATED THAT THE SQUEAKING OF THE VALVES RESULTED FROM A VIBRATION OF THE VALVE LEAFLETS. THIS EFFECT ONLY OCCURS IN A VALVE-DEPENDENT PRESSURE RANGE IN THE LOCKING DIRECTION OF THE VALVE. THE PRESSURE AT THE VALVE IS STRONGLY DEPENDENT ON THE PATIENT'S CIRCULAR SYSTEM, THE IMPLANTED CANNULAS AND THE PATIENT'S BLOOD PROPERTIES. THEREFORE, THE SQUEAKING MAY START OR STOP WHEN THE DRIVE PARAMETERS ARE CHANGED OR THE PATIENT'S MOBILITY CHANGES. THE PUMP WAS PRODUCED ACCORDING TO THE IMPLEMENTED CAPA MEASURES (CP-20-012). THE BLOOD PUMP WAS EXCHANGED. THE PATIENT HAD NO LASTING EFFECTS. TO REDUCE THE OCCURRENCE OF INCIDENTS WITH THE SAME FAILURE PATTERNS, BERLIN HEART IS WORKING ON FURTHER MEASURES.

    Additional Manufacturer Narrative · 0

    THE EXCOR BLOOD PUMP, S/N (B)(6) ON THE PATIENT SINCE (B)(6) 2024 UNTIL THE PUMP EXCHANGE ON (B)(6) 2024 (9 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.

    Description of Event or Problem · 0

    BERLIN HEART GMBH WAS INFORMED BY THE CLINIC THAT A WHISTLING AND A SQUEAKING SOUND OF THE EXCOR PUMP WAS NOTED IN A PATIENT IMPLANTED ON (B)(6) 2024. THE PATIENT'S LDH VALUE SHOWED HEMOLYSIS. BERLIN HEART RECOMMENDED A PUMP EXCHANGE. LATER, THE SITE INFORMED THAT THE PATIENT'S LDH LEVEL INCREASED TO 895 AND THE PUMP WAS REPLACED ON (B)(6) 2024. AFTER THE PUMP CHANGE THE LDH LEVEL DECREASED TO 705 ON (B)(6) 2024. ACCORDING TO THE SITE, THE PUMP MAINTAINED FULL FILL AND EJECTION AND FUNCTIONED AS INTENDED. THE PATIENT REMAINS CLINICALLY STABLE SINCE THE PUMP REPLACEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1928625 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 24 MO Male Other