BEUDAMED
    FDA Adverse Event Death Summary report: N

    EXCOR®

    MDR report key: 23468576 · Received November 4, 2025

    Report

    Report Number
    3008454189-2025-00021
    Event Type
    Death
    Date Received
    November 4, 2025
    Date of Event
    October 5, 2025
    Report Date
    November 4, 2025
    Manufacturer
    BERLIN HEART GMBH
    Product Code
    DSQ
    UDI-DI
    04260090040119
    Adverse Event
    Yes
    Report Source
    Distributor report
    Reporter Location
    MO, US
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE RVAD 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 PATIENT WAS ESCALATED TO CONTINUOUS FLOW (RIGHT SIDE ONLY) ON (B)(6) 2025. THE EVENT OCCURRED ON 2025-10-05, WHICH IS 6 DAYS AFTER THE PATIENT WAS ESCALATED TO CONTINUOUS FLOW. WE HAVE REVIEWED THE PRODUCTION RECORDS OF THE RVAD EXCOR BLOOD PUMP AND CONCLUDED 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 WHO WAS PREVIOUSLY SUPPORTED IN A BVAD CONFIGURATION HAD BEEN ESCALATED ON (B)(6) 2025 TO CONTINUOUS FLOW CIRCUIT ON THE RIGHT SIDE. ON (B)(6) 2025, THE OVERALL CONDITION OF THE PATIENT HAD WORSENED AND THEREFORE THE PATIENT WAS SEDATED AND CHEMICALLY PARALYZED FOR HEMODYNAMIC INSTABILITY. ON (B)(6) 2025, THE TEAM NOTED PUPILLARY CHANGES FOLLOWED BY POSSIBLE SEIZURE ACTIVITY AND POSTURING, PROMPTING A CT SCAN. IMAGING REVEALED EXTENSIVE INTRAVENTRICULAR HEMORRHAGE AND A NEW LARGE RIGHT PARIETAL INTRAPARENCHYMAL HEMORRHAGE. AN EEG PERFORMED FROM (B)(6) 2025 DEMONSTRATED A SEVERELY SUPPRESSED BACKGROUND, CONSISTENT WITH SEVERE DIFFUSE NEURONAL DYSFUNCTION AND ENCEPHALOPATHY. NEUROSURGICAL CONSULTATION DETERMINED THE FINDINGS WERE CATASTROPHIC AND IRREVERSIBLE, AND NO SURGICAL INTERVENTION WAS OFFERED. NEUROLOGY WAS CONSULTED FOR SEIZURE MANAGEMENT AND MEDICAL STABILIZATION. DUE TO POOR NEUROLOGICAL PROGNOSIS, THE PATIENT WAS WITHDRAWN FROM CARE UPON REQUEST BY THE PATIENT'S FAMLIY AND WAS EXPIRED ON (B)(6) 2025.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1744464 EXCOR® VENTRICULAR (ASSIST) BYPASS DSQ BERLIN HEART GMBH P25P-001 04260090040119

    Patients

    Seq Age Sex Outcome Treatment
    1 24 MO Female Death