BEUDAMED
    FDA Adverse Event Injury Summary report: N

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

    MDR report key: 12334706 · Received August 17, 2021

    Report

    Report Number
    3004582654-2021-00039
    Event Type
    Injury
    Date Received
    August 17, 2021
    Date of Event
    July 30, 2021
    Report Date
    August 17, 2021
    Manufacturer
    BERLIN HEART GMBH
    Product Code
    DSQ
    UDI-DI
    04260090040157
    PMA / PMN Number
    P160035
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    117

    Narratives

    Additional Manufacturer Narrative · 0

    DURING INITIAL VISUAL EXAMINATION OF THE RETURNED BLOOD PUMP, NO DEFECT COULD BE DETECTED. THE BLOOD PUMP WAS THEN TESTED FOR FUNCTIONAL PERFORMANCE, WHERE IT MET ITS REQUIRED FUNCTIONAL PERFORMANCE. THE SQUEAKING NOISE REPORTED BY THE CUSTOMER COULD BE REPRODUCED. ANALYSIS OF THE VALVE LEAFLETS SHOWED NO DEFECTS. IT WAS DEFECTED THAT THE THICKNESS PROFILE OF THE LEAFLETS IN THE VALVE VARIED SLIGHTLY, HOWEVER, THE LEAFLETS WERE WITHIN PRODUCTION SPECIFICATIONS. THIS VARIATION IN THICKNESS PROFILE WAS NOTED IN BOTH VALVES OF THE PUMP. THE VALVES WERE CHECKED AT BERLIN HEART DURING PRODUCTION. THE PRODUCTION RECORDS SHOWED THAT ALL THE VALVES WERE IN SPECIFICATION. THE SQUEAKING NOISES COULD BE CONFIRMED THROUGH THE ANALYSIS. BASED ON INVESTIGATION FINDINGS, IT WAS DETERMINED THAT THE SQUEAKING OF THE VALVE WAS RELATED TO VIBRATION OF THE LEAFLETS. HEMOLYSIS ALSO MAY BE RELATED TO THE VIBRATION OF THE LEAFLETS. HISTORICALLY, THE SQUEAKING NOISE THAT THE SITE REPORTED HAS BEEN REPORTED VERY INFREQUENTLY. HOWEVER, MORE EVENTS HAVE BEEN REPORTED RECENTLY. BERLIN HEART GMBH, THE MANUFACTURER OF THE BLOOD PUMPS, HAS INVESTIGATED THESE REPORTS AND HAS IMPLEMENTED ADDITIONAL TESTING TO IDENTIFY THE BLOOD PUMPS WITH SQUEAKING VALVES DURING THE PRODUCTION PROCESS.

    Additional Manufacturer Narrative · 1

    THE EXCOR BLOOD PUMP, S/N, (B)(4) WAS IN USE BY THE PATIENT FROM (B)(6) 2021 UNTIL (B)(6) 2021 (5 DAYS).

    Description of Event or Problem · 1

    ON (B)(6) 2021, THE SITE CONTACTED BERLIN HEART INC. CLINICAL AFFAIRS TO REPORT THAT THE BLOOD PUMP WAS MAKING A SQUEAKING NOISE IN A PATIENT IN THE LVAD CONFIGURATION. THE NOISE HAD BEGUN ON (B)(6) 2021. THE PUMP HAD FULL FILL AND EJECTION. A BERLIN HEART CLINICAL SPECIALIST WAS ON SITE FOR THE IMPLANT THAT TOOK PLACE ON (B)(6) 2021. THE PATIENT DEVELOPED HEMOLYSIS PRIOR TO THE BERLIN HEART IMPLANTATION WITH A REPORTED LDH LEVEL ON (B)(6) 2021 OF 2997 AND A PLASMA FREE HEMOGLOBIN LEVEL OF 33. POST-IMPLANT OF THE EXCOR VAD SYSTEM, THE HEMOLYSIS REPORTED PRE IMPLANTATION CONTINUED TO RISE. ON (B)(6) 2021, THE DAY AFTER IMPLANTATION, THE LDH VALUE WAS 3200 AND THE PLASMA FREE HEMOGLOBIN WAS 20. ON (B)(6) 2021, THE LDH WAS REPORTED AS 3400 AND THE PLASMA FREE HEMOGLOBIN AS 17. ON (B)(6) 2021, THE LDH INCREASED TO 4760 AND THE PLASMA FREE HEMOGLOBIN TO 38. THE PUMP CONTINUED TO FULLY FILL AND EJECT WITH NO NOTED DEPOSITS IN THE PUMP. THE BLOOD PUMP WAS CHANGED ON (B)(6) 2021 WITH NO UNTOWARD EFFECTS TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1231937 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 Female Other