BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DIAPACT CRRT MONITOR US

    MDR report key: 3450184 · Received September 26, 2013

    Report

    Report Number
    2523676-2013-00276
    Event Type
    Malfunction
    Date Received
    September 26, 2013
    Date of Event
    August 30, 2013
    Report Date
    August 30, 2013
    Manufacturer
    B. BRAUN MEDICAL, INC.
    Product Code
    KDI
    Product Problem
    Yes
    Report Source
    Distributor report
    Reporter Location
    GA, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Description of Event or Problem · 1

    AS REPORTED BY THE USER FACILITY: DOCTOR CLAIMS THAT BOTH DIAPACT MACHINES AT FACILITY HAVE CAUSED HEMOLYSIS ON A SINGLE PT BECAUSE THE ULTRAFILTRATION BAG IS FILLED WITH DARK FLUID. DOCTOR WANTS BOTH DIAPACT MACHINES FUNCTION CHECKED BY B. BRAUN CUSTOMER ENGINEER TO CONFIRM PROPER OPERATION. ADD'L INFO RECEIVED BY E-MAIL. PT RECEIVED PEX (PLASMA EXCHANGE) THERAPY. ASAHI PLASMA FILTER WAS USED. ICU PT. MFR REF # 3002879653-2013-00276.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    488027 DIAPACT CRRT MONITOR US HEMODIALYSIS SYSTEM KDI B. BRAUN MEDICAL, INC. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK