BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COMBISET ACCESS FLOW REVERSE FLOW TWISTER

    MDR report key: 1022629 · Received March 31, 2008

    Report

    Report Number
    8030665-2008-00016
    Event Type
    Malfunction
    Date Received
    March 31, 2008
    Date of Event
    March 6, 2008
    Report Date
    April 1, 2008
    Manufacturer
    REYNOSA MANUFACTURING
    Product Code
    FJK
    PMA / PMN Number
    K022536
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    AN ELECTRONIC REPORT WAS RECEIVED FROM A HEMODIALYSIS USER FACILITY. THE RN REPORTED THAT THE DIALYSIS TREATMENT WAS STARTED WHEN APPROXIMATELY 10 MINUTES INTO THE DIALYSIS TREATMENT, THE ARTERIAL LINE SEPARATED FROM THE TWISTER DEVICE. THE RN REPORTED THAT THE INCIDENT WAS DETECTED BY THE RN WHO WAS PROVIDING THE CARE. A STAT HEMOGLOBIN WAS DRAWN AND THE RESULTS WERE NORMAL. THE PATIENT WAS ABLE TO RESTARTED FOR THEIR TREATMENT AND WAS ABLE TO COMPLETE THE PRESCRIBED DIALYSIS TREATMENT WITH THE USE OF A NEW TREATMENT SET. THE ENTIRE DIALYSIS TREATMENT WAS COMPLETED AS ORDERED WITHOUT FURTHER INCIDENCE. A SAMPLE IS AVAILABLE FOR AN EVALUATION. THE ESTIMATED BLOOD LOSS THAT WAS REPORTED FOR THIS EVENT WAS APPROXIMATELY 200 ML.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COMBISET ACCESS FLOW REVERSE FLOW TWISTER HEMODIALYSIS BLOODLINES FJK REYNOSA MANUFACTURING NA 7LR050

    Patients

    Seq Age Sex Outcome Treatment
    1 NA