BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SURETRANS

    MDR report key: 681513 · Received February 24, 2006

    Report

    Report Number
    1213643-2006-00051
    Event Type
    Malfunction
    Date Received
    February 24, 2006
    Date of Event
    January 26, 2006
    Report Date
    January 26, 2006
    Manufacturer
    DAVOL INC., SUB. C.R. BARD, INC.
    Product Code
    CAC
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    INVALID DATA

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL MANUFACTURER NARRATIVE AS FOLLOWS: COMPLAINT CONFIRMED. THIS WAS DUE BLOOD CLOTS IN THE BOTTLE TRANSFER PORT AND IN THE TRANSFER TUBE PREVENTING BLOOD FLOW TO THE REINFUSION BAG.

    Description of Event or Problem · 1

    THE CONTAINER IS FILLED WITH A BLOOD CLOT. THE BLOOD CLOT DAMNED UP A WAY OF CONTAINER. AS A RESULT CANT MOVE TO BLOOD BAG.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SURETRANS AUTOTRANSFUSION APARATUS CAC DAVOL INC., SUB. C.R. BARD, INC. * 41HPN007

    Patients

    Seq Age Sex Outcome Treatment
    1 *