BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EXCOR®

    MDR report key: 17952554 · Received October 17, 2023

    Report

    Report Number
    3004582654-2023-00033
    Event Type
    Injury
    Date Received
    October 17, 2023
    Date of Event
    September 21, 2023
    Report Date
    June 20, 2024
    Manufacturer
    BERLIN HEART GMBH
    Product Code
    DSQ
    UDI-DI
    04260090040102
    PMA / PMN Number
    P160035
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    NURSE
    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 INCIDENT ON (B)(6) 2023 (77 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 05/20/2024. 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 (B)(4).

    Description of Event or Problem · 0

    BERLIN HEART WAS INFORMED BY THE CLINIC THAT A PATIENT HAD AN EYE DEVIATION TO THE RIGHT DURING PO FEEDING. NO OTHER NEUROLOGICAL CHANGES WERE NOTED AT THAT TIME. ON (B)(6) 2023-HEAD CT CONFIRMED A SMALL ISCHEMIC CVA. ANTICOAGULATION WAS HELD PENDING COAGULATION LAB RESULTS. NEUROLOGY CONSULTED, AND THE DECISION TO RESTART ANTICOAGULATION WAS MADE. SEIZURE ACTIVITY WAS NOTED LATER ON (B)(6) 2023, THE PATIENT WAS GIVEN ATIVAN AND LOADED WITH KEPPRA, WHICH CONTINUES. OF NOTE: SITE REPORTED THAT ON (B)(6) 2023 TWO SMALL FIBRIN DEPOSITS WERE NOTED IN THE PUMP AND THEN DISAPPEARED. PATIENT'S NEUROLOGICAL STATUS WAS STABLE AT THE TIME, AND NEURO CHECKS WERE CHANGED FROM Q4 HOURS TO Q1 HOUR FOR 4 HOURS. NO NEURO CHANGES WERE NOTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    83174 EXCOR® VENTRICULAR (ASSIST) BYPASS DSQ BERLIN HEART GMBH P10P-001 04260090040102

    Patients

    Seq Age Sex Outcome Treatment
    1 4 MO Male Other