BEUDAMED
    FDA Adverse Event Death Summary report: N

    EXCOR®

    MDR report key: 23255523 · Received October 9, 2025

    Report

    Report Number
    3004582654-2025-00051
    Event Type
    Death
    Date Received
    October 9, 2025
    Date of Event
    September 7, 2025
    Report Date
    October 9, 2025
    Manufacturer
    BERLIN HEART GMBH
    Product Code
    DSQ
    PMA / PMN Number
    P160035
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UT, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE LVAD EXCOR BLOOD PUMP PU VALVES; 25 ML IN/OUT; Ø 9 MM; SN (B)(6) WAS IN USE ON THE PATIENT FROM (B)(6) 2025 UNTIL THE PUMP WAS EXPLANTED ON (B)(6) 2025. THE EVENT OCCURRED ON (B)(6) 2025, WHICH IS (367 DAYS) AFTER THE PUMP WAS PLACED ON THE PATIENT. WE HAVE REVIEWED THE PRODUCTION RECORDS OF THE EXCOR BLOOD PUMP AND CONCLUDED THAT THE PUMP WAS PRODUCED ACCORDING TO OUR SPECIFICATION.

    Description of Event or Problem · 0

    THE SITE CONTACTED BERLIN HEART INC (BHI) CLINICAL AFFAIRS (CA) ON (B)(6) 2025 TO REPORT THAT THE PATIENT WAS TAKEN TO THE OR TO UNDERGO A HEART TRANSPLANT ON (B)(6) 2025. THE PATIENT WAS BEING SUPPORTED WITH EXCOR PEDIATRIC VENTRICULAR ASSIST DEVICE IN BI-VAD CONFIGURATION WITH RA/PA CANNULATION FOR THE RVAD AND LA/AO CANNULATION FOR THE LVAD. THE CHEST WAS OPENED, AND THE SURGEON DISSECTED AROUND THE BERLIN CANNULAS IN PREPARATION TO TRANSITION FROM VAD SUPPORT TO CARDIOPULMONARY BYPASS FOR THE PROCEDURE. THE SURGEON CANNULATED THE AORTA AND SVC, HOWEVER, COULD NOT CANNULATE THE IVC AND COULD NOT ACHIEVE ADEQUATE FLOW THROUGH THE CARDIOPULMONARY BYPASS CIRCUIT. THE DECISION WAS THEN MADE TO CONNECT THE RA CANNULA FROM THE RVAD TO AUGMENT THE VENOUS RETURN TO BYPASS CIRCUIT AND IMPROVE THE FLOW. THE RVAD WAS STOPPED, THE RA AND PA CANNULAS WERE CLAMPED AND THEN THE RA CANNULA WAS CUT TO BE CONNECTED TO THE BYPASS CIRCUIT. WHEN THE CLAMP WAS REMOVED FROM THE CANNULA A LARGE AMOUNT OF AIR WAS INSTANTLY ENTRAINED INTO THE AORTIC CANNULA. THE RA CANNULA THAT HAD BEEN CUT WAS CLAMPED AGAIN, AND IT WAS THEN DISCOVERED THAT THE LA CANNULA HAD BEEN CUT AND NOT THE RA CANNULA AS INTENDED. WHEN THE CLAMP WAS REMOVED FROM THE LA CANNULA THE LVAD BLOOD PUMP RUNNING AT A RATE OF 80BPM, FILLED WITH AIR WHICH WAS PUMPED TO THE PATIENT. THE BYPASS CANNULA FROM THE SVC WAS THEN USED FOR RETROGRADE CEREBRAL PERFUSION FOR 30 MINUTES UNTIL NO FURTHER AIR WAS SEEN. THE PATIENT UNDERWENT THE HEART TRANSPLANT AND WAS TRANSFERRED TO ICU FOR RECOVERY. APPROXIMATELY 12 HOURS LATER THE PATIENT BEGAN SEIZING. THE DECISION TO WITHDRAW CARE WAS MADE BY FAMILY ON (B)(6) 2025 AS THE PATIENT EXPERIENCED DIFFUSE CEREBRAL EDEMA AND BRAIN DEATH. THE EXCOR BLOOD PUMP MAINTAINED FULL FILLING AND EJECTION PRIOR TO INADVERTENTLY CUTTING THE LA CANNULA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2609698 EXCOR® VENTRICULAR (ASSIST) BYPASS DSQ BERLIN HEART GMBH P25P-001X01

    Patients

    Seq Age Sex Outcome Treatment
    1 24 MO Male Death