BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EXCOR®

    MDR report key: 21027069 · Received December 27, 2024

    Report

    Report Number
    3004582654-2024-00072
    Event Type
    Malfunction
    Date Received
    December 27, 2024
    Date of Event
    November 29, 2024
    Report Date
    June 17, 2025
    Manufacturer
    BERLIN HEART GMBH
    Product Code
    DSQ
    UDI-DI
    04260090040102
    PMA / PMN Number
    P160035
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    HK
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THE PATIENT IS BEING SUPPORTED WITH AN EXCOR PEDIATRIC SYSTEM IN BI-VAD CONFIGURATION. THE EXCOR BLOOD PUMP PU VALVES; 10 ML IN/OUT; Ø 6 MM; LVAD SN (B)(6) WAS IN USE ON THE PATIENT FROM (B)(6) 2024 TO DATE. THE AFFECTED PUMP, SN (B)(6) REMAINS ON THE PATIENT AND CONTINUES TO BE MONITORED. THE EVENT OCCURRED ON (B)(6) 2024, (42 DAYS) AFTER THE PUMP WAS PLACED ON THE PATIENT. WE HAVE REVIEWED THE PRODUCTION RECORDS OF THE EXCOR BLOOD PUMP AND THE PUMP WAS PRODUCED ACCORDING TO OUR SPECIFICATION. A DETAILED INVESTIGATION REPORT WILL BE PROVIDED AS SOON AS IT IS AVAILABLE. THE OTHER PUMP RVAD, SN (B)(6) ASSOCIATED WITH THIS EVENT IS SUBMITTED AS 3004582654-2024-00073. THE EVENT ASSOCIATED WITH HEMOLYSIS OF LVAD PUMP (SN (B)(6)) AND RVAD PUMP (SN (B)(6)) HAVE BEEN SUBMITTED AS 3004582654-2024-00070 & 3004582654-2024-00071.

    Additional Manufacturer Narrative · 0

    THE EVENT OCCURRED ON 2024-11-29, WHICH IS (42 DAYS) AFTER THE PUMP IN QUESTION WAS PLACED ON THE PATIENT. THE PUMP CONTINUED TO REMAIN ON THE PATIENT FOR FURTHER 79 DAYS FROM THE TIME OF THE EVENT UNTIL TRANSPLANTATION ON (B)(6) 2025. THE AFFECTED LVAD PUMP WAS NOT RETURNED TO BERLIN HEART FOR INVESTIGATION AS THE PUMP WAS DISPOSED OF AFTER TRANSPLANTATION. THERE WAS NO ADVERSE EFFECT TO THE PATIENT AND THAT THE PATIENT WAS TRANSPLANTED WITHOUT INCIDENT. THEREFORE, NEITHER THE EXACT FAILURE NOR THE CAUSE OF THE FAILURE IN QUESTION COULD BE DETERMINED.

    Description of Event or Problem · 0

    A PHYSICIAN CONTACTED BERLIN HEART GMBH CLINICAL AFFAIRS TO REPORT DIASTOLIC REGURGITATION WITH THRILL ON THE OUTLET OF BOTH PUMPS AS THE ULTRASOUND SONOGRAPHY (USG) SHOWED LEAKING OF THE OUTFLOW VALVE. ACCORDING TO THE SITE, THE PATIENT HAD EXPERIENCED HEMOLYSIS SINCE IMPLANTATION. THE PATIENT IS TRANSFUSION DEPENDENT WITH ELEVATED LDH VALUE. THE PATIENT IS CLINICALLY STABLE THROUGHOUT. BH CA RECOMMENDED A PUMP CHANGE, HOWEVER, THE SITE STATED THAT THEY WOULD CLOSELY MONITOR THE PATIENT. THE PATIENT IS BEING SUPPORTED WITH AN EXCOR SYSTEM IN BI-VAD CONFIGURATION. BOTH PUMPS ARE BLOOD PUMP PU VALVES; 10 ML IN/OUT; Ø 6 MM: LVAD (SN (B)(6)) AND RVAD (SN (B)(6)) AND ARE STILL IN USE ON THE PATIENT SINCE (B)(6) 2024.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2511368 EXCOR® VENTRICULAR (ASSIST) BYPASS DSQ BERLIN HEART GMBH P10P-001 04260090040102

    Patients

    Seq Age Sex Outcome Treatment
    1 5 MO Female