BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MEDISYSTEMS HEMODIALYSIS BLOOD TUBING SET

    MDR report key: 1040166 · Received May 9, 2008

    Report

    Report Number
    3003464075-2008-00195
    Event Type
    Injury
    Date Received
    May 9, 2008
    Date of Event
    March 26, 2008
    Report Date
    April 3, 2008
    Manufacturer
    NXSTAGE MEDICAL, INC.
    Product Code
    FJK
    PMA / PMN Number
    K953823
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THE USER FACILITY REPORTS INCIDENT OF A LEAK AT THE CONNECTION BETWEEN THE DIALYZER PORT AND THE BLOODLINE DIALYZER CONNECTOR. DUE TO POTENTIAL FOR CONTAMINATION THE PT'S BLOOD WAS NOT RETURNED RESULTING IN EBL = 200CC. NO PT INJURY OR NEED FOR MEDICAL INTERVENTION IS REPORTED. THE COMPLAINT SAMPLE WAS DISCARDED AT THE TIME OF THE EVENT. THIS REPORT IS BEING FILED AS AN ADVERSE EVENT SOLELY TO COMPLY WITH THE FDA'S BLOOD LOSS POLICY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MEDISYSTEMS HEMODIALYSIS BLOOD TUBING SET HEMODIALYSIS BLOOD TUBING SET FJK NXSTAGE MEDICAL, INC. NA 8025111

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Other