BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DIALINES ARTERIAL AND VENOUS BLOOD TUBING SET

    MDR report key: 708970 · Received May 2, 2006

    Report

    Report Number
    9616074-2006-00029
    Event Type
    Malfunction
    Date Received
    May 2, 2006
    Date of Event
    April 4, 2006
    Report Date
    April 4, 2006
    Manufacturer
    MEDISYSTEMS CORP
    Product Code
    FJK
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THE USER FACILITY REPORTS LEAK BETWEEN THE ARTERILA CHAMBER AND CAP. DUE TO POTENTIAL FOR CONTAMINATION, THE BLOOD VOLUME IN THE ARTERIAL PORTION OF THE CIRCUIT WAS DISCARDED RESULTING IN EML = 81CC. THERE WAS NO PT INJURY OR NEED FOR MEDICAL INTERVENTION REPORTED. THIS MDR IS FILED FOR BLOOD LOSS ONLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DIALINES ARTERIAL AND VENOUS BLOOD TUBING SET HEMODIALYSIS BLOOD TUBING SET FJK MEDISYSTEMS CORP NA 5045116

    Patients

    Seq Age Sex Outcome Treatment
    1 43 YR Other