BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LEVCOREDUCTION FILTER

    MDR report key: 5404929 · Received July 9, 2004

    Report

    Report Number
    9710488-2004-00001
    Event Type
    Malfunction
    Date Received
    July 9, 2004
    Date of Event
    May 20, 2004
    Report Date
    July 9, 2004
    Manufacturer
    MACOPRODUCTIONS S.A.S.
    Product Code
    MAC
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    NO. 133900 FILTER SIMILAR PRODUCTS SOLD IN (B)(6) WITHOUT ANY COMPLAINT ABOUT LEAK. POTENTIAL CONTAMINATION VERY LOW. INVESTIGATION STILL ONGOING AT THIS DATE.

    Description of Event or Problem · 1

    LOSS OF INTEGRITY OF THE FILTER DURING FILTRATION. BLOOD LEAKED FROM FILTER. FILTRATION CONDITION: BLOOD STORAGE 1 DEGREE BEFORE FILTRATION 22 CELSIUS. BLOOD STORAGE TIME BEFORE FILTRATION 5 HOURS. FILTRATION 1 DEGREE - 22 CELSIUS. FILTRATION TIME; APPROX. 6MM. BLOOD CENTER: GULF COAST. DURATION NUMBER: (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LEVCOREDUCTION FILTER MEDICAL DEVICE MAC MACOPRODUCTIONS S.A.S. KSV0002XD 284803G22

    Patients

    Seq Age Sex Outcome Treatment
    1