BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CUSTOM COMBI SET 2008

    MDR report key: 3963695 · Received May 1, 2014

    Report

    Report Number
    8030665-2014-00341
    Event Type
    Malfunction
    Date Received
    May 1, 2014
    Date of Event
    April 2, 2014
    Report Date
    April 3, 2014
    Manufacturer
    REYNOSA MANUFACTURING
    Product Code
    FJK
    PMA / PMN Number
    K962081
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS DISPOSED OF AND IS NOT AVAILABLE FOR PHYSICAL EVALUATION. A PLANT INVESTIGATION IS IN PROGRESS AND A SUPPLEMENTAL REPORT WILL BE SUBMITTED UPON COMPLETION.

    Description of Event or Problem · 1

    THE USER FACILITY REPORTED THAT THE BLOODLINE WAS IMPROPERLY SECURED, ALLOWING AIR INTO THE LINE DURING TREATMENT. ACCORDING TO THE CERTIFIED CLINICAL HEMODIALYSIS TECHNICIAN, THERE WAS A LOOSE CONNECTION WHERE THE BLOODLINE TWISTS ONTO THE FISTULA NEEDLE TUBING. SHE SAID THERE WAS NOTHING WRONG WITH THE DEVICE; SHE HAD MDE THE CONNECTION HERSELF AND IT SEEMED TIGHT, BUT IT HAD APPARENTLY BEEN TWISTED AT A SLIGHT ANGLE SO THAT IT WAS CROSS-THREADED, WHICH ALLOWED AIR TO BE SUCKED IN DURING USE. THE AIR WAS CAPTURED WITHIN THE DRIP CHAMBER AND NEVER MADE IT INTO THE PT. SHE USED A 10 CC SYRINGE TO TRY AND REMOVE THE AIR FROM THE DRIP CHAMBER WHEN THE PLUNGER OF THE SYRINGE CAME OUT OF THE BARREL OF THE SYRINGE, CAUSING BLOOD TO SPURT OUT OF THE SYRINGE. TREATMENT WAS RESUMED AND COMPLETED WITH NO COMPLICATIONS TO THE PT, WHO LOST 10 CC BLOOD AND WAS FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    261261 CUSTOM COMBI SET 2008 FJK REYNOSA MANUFACTURING

    Patients

    Seq Age Sex Outcome Treatment
    1 FRESENIUS 2008K HEMODIALYSIS MACHINE