BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SINGLE NEEDLE BLOOD TUBING SET

    MDR report key: 3101874 · Received May 3, 2013

    Report

    Report Number
    8030665-2013-00256
    Event Type
    Malfunction
    Date Received
    May 3, 2013
    Date of Event
    April 4, 2013
    Report Date
    April 5, 2013
    Manufacturer
    REYNOSA MANUFACTURING
    Product Code
    FJK
    PMA / PMN Number
    K000451
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS NOT RETURNED TO THE MFR FOR PHYSICAL EVAL AND THE FAILURE MODE CANNOT BE CONFIRMED. HOWEVER, AN INVESTIGATION OF THE DEVICE MANUFACTURING RECORDS WAS CONDUCTED BY THE MFR. THERE WERE NO DEVIATION OR NONCONFORMANCES DURING THE MANUFACTURING PROCESS. IN ADDITION, THE BATCH RECORD REVIEW CONFIRMED THE LABELING, MATERIAL AND PROCESS CONTROLS WERE WITHIN SPECIFICATION.

    Description of Event or Problem · 1

    A HOME PT, (B)(6), HAS REPORTED THAT DURING TREATMENT A BLOOD LEAD OCCURRED. THE LEAK WAS VISUALLY OBSERVED AND THE MACHINE ALARMED. ESTIMATED BLOOD LOSS WAS 300 ML'S. THERE ARE NO PT ILL EFFECTS AND NO MEDICAL INTERVENTION REQUIRED. THE PT OPENED A NEW SETUP AND NOTICED THE SAME DEFECT DURING PRETREATMENT SETUP, THAT THE BALANCE CHAMBER CONNECTION WAS OVAL AND NOT ROUND. THE PT DID NOT DIALYZE. SAMPLE WAS CONTAMINATED WITH BLOOD AND IS NOT AVAILABLE FOR INVESTIGATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    195342 SINGLE NEEDLE BLOOD TUBING SET FJK22 FJK REYNOSA MANUFACTURING 12AR01175

    Patients

    Seq Age Sex Outcome Treatment
    1 FRESENIUS 2008K AT HOME MACHINE