BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DIAPACT CRRT MONITOR US

    MDR report key: 3450088 · Received September 26, 2013

    Report

    Report Number
    3002879653-2013-00276
    Event Type
    Malfunction
    Date Received
    September 26, 2013
    Manufacturer
    B. BRAUN MEDICAL INC.
    Product Code
    KDI
    PMA / PMN Number
    K963440
    Removal / Correction Number
    NA
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THIS REPORT HAS BEEN IDENTIFIED AS B. BRAUN AVITUM (B)(4) INTERNAL REPORT #(B)(4). A B. BRAUN SERVICE CUSTOMER TECH HAS TESTED AND CHECKED THE MACHINE AS REQUESTED BY THE CUSTOMER. THE BLOOD LEAK DETECTOR WAS ALSO CHECKED AND THERE WAS NO MALFUNCTION. THE MACHINE PASSED THE TECHNICAL SAFETY INSPECTION AND THERE WERE NO MALFUNCTIONS NOTED. THE MACHINE PERFORMED WITHIN SPEC. A REVIEW OF THE CUSTOMER COMPLAINT DATABASE, DATING BACK TWO YEARS, REVEALED NO SIMILAR COMPLAINTS CONCERNING THIS DEVICE. SINCE THERE IS NO PRODUCT DEVIATION, NO FURTHER MEASURES WILL BE TAKEN. ACCORDING TO THE PT INFO, THE PT HAS A LIVER DISEASE. IT IS PRESUMED THAT A HIGH BILIRUBIN VALUE IS THE ROOT CAUSE FOR THE DARK FILTRATE. ALL AVAILABLE INFO HAS BEEN FORWARDED TO THE ACTUAL MFR. IF ADD'L PERTINENT INFO BECOMES AVAILABLE, A F/U REPORT WILL BE SUBMITTED.

    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 BY E-MAIL: PT RECEIVED PEX (PLASMA EXCHANGE) THERAPY. ASAHI PLASMA FILTER WAS USED. ICU PT. INP REF # (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    487652 DIAPACT CRRT MONITOR US HEMODIALYSIS SYSTEM KDI B. BRAUN MEDICAL INC. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1