BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COMBISET WITH BVM

    MDR report key: 1053204 · Received May 28, 2008

    Report

    Report Number
    8030665-2008-00029
    Event Type
    Malfunction
    Date Received
    May 28, 2008
    Date of Event
    April 23, 2008
    Report Date
    May 28, 2008
    Manufacturer
    REYNOSA MANUFACTURING
    Product Code
    FJK
    PMA / PMN Number
    K962081
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PR, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    RECEIVED AN ELECTRONIC REPORT FROM A HEMODIALYSIS UNIT. THE EVENT REPORTED WAS THAT A LEAK WAS NOTED ON THE ARTERIAL LINE. THE LINE THEN SEPARATED. THE FACILITY WAS CONTACTED FOR FURTHER DETAIL. IT WAS LEARNED THAT BLOOD WAS IN THE LINE AT THE INITIATION OF TREATMENT, TRIED TO EXAMINE THE LINE, AND IT THEN SEPARATED. THE ESTIMATED BLOOD LOSS FOR THE EVENT WAS REPORTED AS 110ML. THERE WAS NO ILL EFFECT TO THE PATIENT. NEW LINES WERE SET UP AND THE TREATMENT WAS COMPLETED WITHOUT FURTHER INCIDENCE. THE SEGMENT OF THE LINE THAT HAD THE PROBLEM HAS BEEN SAVED FOR AN EVALUATION. THE PATIENT COMPLETED DIALYSIS AND WAS DISCHARGED TO HOME WITHOUT ANY REPORT OF FURTHER ILL EFFECT OR INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COMBISET WITH BVM HEMODIALYSIS BLOODLINES FJK REYNOSA MANUFACTURING NA 7KR225

    Patients

    Seq Age Sex Outcome Treatment
    1 NA