BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CUSTOM COMBI SET

    MDR report key: 869194 · Received June 21, 2007

    Report

    Report Number
    8030665-2007-00047
    Event Type
    Malfunction
    Date Received
    June 21, 2007
    Date of Event
    May 24, 2007
    Report Date
    June 21, 2007
    Manufacturer
    REYNOSA MANUFACTURING
    Product Code
    FKJ
    PMA / PMN Number
    K962081
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    AN ELECTRONIC REPORT FROM A HEMODIALYSIS USER FACILITY WAS RECEIVED THAT REPORTED THAT A PIECE OF TUBING NEAR THE VENOUS CONNECTOR FELL APART AFTER THE HEMODIALYSIS TREATMENT WAS INITIATED. THE FACILITY WAS CONTACTED FOR ADDITIONAL INFO. IT WAS LEARNED THAT THE STAFF FOUND SOME BLOOD ON THE FLOOR AND THEN NOTED A PIECE OF THE TUBING NEAR THE CONNECTOR SEPARATED ON THE VENOUS LINE. AS A RESULT OF THIS EVENT, IT WAS REPORTED A TOTAL EBL OF > 100 ML TO THIS PT. THIS OCCURRED AT ONSET OF THE DIALYSIS TREATMENT. A NEW VENOUS LINE WAS SET UP AND THE DIALYSIS THERAPY WAS CONTINUED AND COMPLETED AS ORDERED. ALSO, THE RN REPORTED THERE WAS NO ILL EFFECT TO THE PT. A SAMPLE WAS SAVED. THE PT DID COMPLETE DIALYSIS WITH NO FURTHER ILL EFFECT RESULTING FROM THIS EVENT. THE PT WAS DISCHARGED TO HOME WHEN THE TREATMENT WAS COMPLETED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CUSTOM COMBI SET HEMODIALYSIS BLOOD TUBING FKJ REYNOSA MANUFACTURING NA 7CR373

    Patients

    Seq Age Sex Outcome Treatment
    1 NA YR