BEUDAMED
    FDA Adverse Event Injury Summary report: N

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

    MDR report key: 18842044 · Received March 5, 2024

    Report

    Report Number
    3004582654-2024-00012
    Event Type
    Injury
    Date Received
    March 5, 2024
    Date of Event
    February 22, 2024
    Report Date
    April 18, 2024
    Manufacturer
    BERLIN HEART GMBH
    Product Code
    DSQ
    UDI-DI
    04260090040126
    PMA / PMN Number
    P160035
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, 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 ON (B)(6) 2024 UNTIL THE TIME OF THE EVENT ON 2024-02-22 (14 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 (14 DAYS). ON 2024-03-07 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 COULD BE DETECTED. THE BLOOD PUMP WAS TESTED FOR FUNCTIONAL PERFORMANCE. BOTH THE PARAMETERS FROM THE CLINIC, AS WELL AS THE PARAMETERS USED FOR PUMP RELEASE DURING PRODUCTION HAVE BEEN TAKEN INTO CONSIDERATION. THE PUMP PERFORMANCE MET OUR SPECIFICATIONS. THE PUMP WAS COMPLETELY FILLING AND EMPTYING. DURING THE EVALUATION, A NOISE WAS DETECTED EMANATING FROM THE BLOOD PUMP. IN ADDITION TO THE TYPICAL PUMP NOISE, A DISTINCT "SQUEAKING" SOUND COULD ALSO BE HEARD AT THE OUTFLOW VALVE OF THE BLOOD PUMP. A SLIGHT VIBRATION OF THE LEAFLETS WAS DETECTED. THE ANALYSIS OF THE VALVE LEAFLETS SHOWED NO DEFECTS. SQUEAKING NOISES WERE CONFIRMED DURING EVALUATION. THE VALVES WERE TESTED DURING PRODUCTION AT BERLIN HEART GMBH AND NO ABNORMALITIES WERE FOUND. DURING OPERATION ON PATIENTS, A SQUEAKING NOISE CAN SOMETIMES OCCUR FROM THE PU VALVES. THIS EFFECT ONLY OCCURS IN A VALVE-DEPENDENT PRESSURE RANGE IN THE PUMP VALVE JUNCTION. 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. IN THIS CASE, THE REPORTED SQUEAKING NOISE AT THE VALVES COULD BE REPRODUCED DURING THE ANALYSIS. A SLIGHT VIBRATION OF THE VALVE LEAFLETS WAS DETECTED. THEREFORE, A CORRELATION BETWEEN THE PUMP AND THE PATIENT'S ELEVATED HEMOLYSIS CANNOT BE EXCLUDED. APPROPRIATE MEASURES WERE IMPLEMENTED BY THE PUMP MANUFACTURER, BERLIN HEART GMBH. THIS PUMP WAS MANUFACTURED BEFORE THE IMPLEMENTATION OF CORRECTIVE ACTION MEASURES.

    Description of Event or Problem · 0

    THE SITE NOTIFIED BERLIN HEART INC. CLINICAL AFFAIRS THAT ON (B)(6) 2024, A PUMP CHANGE WAS PERFORMED DUE TO HEMOLYIS AND SQUEAKING AT THE VALVES, LOUDER AT THE OUTFLOW THAN THE INFLOW VALVE. THE PATIENT'S LDH LEVEL INCREASED FROM 1853 ON (B)(6) 2024 TO 2494 ON (B)(6) 2024. ACCORDING TO THE SITE, THE PUMP MAINTAINED FULL FILL AND EJECTION AND FUNCTIONED AS INTENDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1476862 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 19 MO Male Other