BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EXCOR®

    MDR report key: 18310964 · Received December 12, 2023

    Report

    Report Number
    3004582654-2023-00038
    Event Type
    Injury
    Date Received
    December 12, 2023
    Date of Event
    December 4, 2023
    Report Date
    June 20, 2024
    Manufacturer
    BERLIN HEART GMBH
    Product Code
    DSQ
    UDI-DI
    04260090040119
    PMA / PMN Number
    P160035
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    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 WAS IN USE FROM (B)(6) 2023 UNTIL THE TIME OF THE EXCOR REMOVAL ON (B)(6) 2023 (40 DAYS). WE HAVE REVIEWED THE PRODUCTION RECORDS OF THE EXCOR BLOOD PUMP, S/N (B)(6), THIS PUMP WAS PRODUCED ACCORDING TO OUR SPECIFICATION.

    Additional Manufacturer Narrative · 0

    DATA CORRECTED IN SECTION D TO MATCH DEVICE INFORMATION IN GUDID PER THE FDA LETTER DATED 5/20/2024. D1 CHANGED THE BRAND NAME TO MATCH GUDID D2A CHANGED THE COMMON DEVICE NAME TO MATCH GUDID D4 UDI CHANGED, TO INCLUDE COMPLETE UDI NUMBER (DI+PI) (01) (B)(4).

    Description of Event or Problem · 0

    BERLIN HEART CLINICAL AFFAIRS WAS INFORMED BY JAPAN DISTRIBUTOR THAT A PATIENT HAD A NEUROLOGICAL DYSFUNCTION SYMPTOM. SCHEDULED PUMP EXCHANGE DUE AFTER 1 YEAR OF USE OF THE PUMP WAS POSTPONED DUE TO THE PATIENT'S HEALTH CONDITION (SEVERE INFECTION). WHEN THE PATIENT BECAME STABLE THE PUMP WAS EXCHANGED ON (B)(6) 2023. HOWEVER, A THROMBUS WAS FOUND INSIDE THE NEW PUMP. THEREFORE, THE PUMP WAS CONVERTED FROM EXCOR TO CENTRIFUGAL PUMP (BIOFLOAT) ON (B)(6) 2023. AFTER CONVERSION, HEMIPLEGIA APPEARED ON (B)(6) 2023. TWO CT SCANS REVEALED AN ENLARGED CEREBRAL INFARCTION AND A WIDESPREAD BRAIN TUMOR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1384766 EXCOR® VENTRICULAR (ASSIST) BYPASS DSQ BERLIN HEART GMBH P25P-001X01 04260090040119

    Patients

    Seq Age Sex Outcome Treatment
    1 5 YR Male Other