BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COMBISET WITH BVM

    MDR report key: 1934536 · Received November 23, 2010

    Report

    Report Number
    8030665-2010-00104
    Event Type
    Malfunction
    Date Received
    November 23, 2010
    Date of Event
    October 4, 2010
    Report Date
    November 23, 2010
    Manufacturer
    REYNOSA MANUFACTURING
    Product Code
    FJK
    PMA / PMN Number
    K962081
    Removal / Correction Number
    NI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    NO INFORMATION

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE MFR IS REVIEWING THE DESIGN HISTORY FILE AND MFG RECORDS FOR THIS PRODUCT. IN ADDITION THE MFR HAS MADE VISITS TO THIS CUSTOMER FACILITY TO OBSERVE THE CLINICAL PRACTICE AND COLLECT ADD'L INFO THAT WILL BE HELPFUL TO THE INVESTIGATION. THE INVESTIGATION IS CURRENTLY ONGOING AND A ROOT CAUSE HAS NOT BEEN DETERMINED AT THIS TIME.

    Description of Event or Problem · 1

    A REPORT HAS BEEN RECEIVED FROM (B)(6) OF A BLOOD TUBING BEING OCCLUDED ON ARTERIAL SIDE JUST BEFORE THE BVM CUVETTE CAUSING LOW ARTERIAL PRESSURE. ASSESSMENT OF NEEDLE SHOWED THAT IT WAS FINE. WEIGHT OF TUBING WAS CAUSING LINE OCCLUSION. THE TUBING SEEM HEAVIER AND IS BEING OCCLUDED BY ITS OWN WEIGHT. THERE WAS NO INJURY TO THE PT. NO MEDICAL INTERVENTION REQUIRED. ADD'L INFO RECEIVED 11/23/2010 CONCLUDED THAT THE OCCLUSION WAS CAUSED BY AN ARTERIAL LINE KINK, JUST BEFORE THE BVM CUVETTE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COMBISET WITH BVM DIALYSIS BLOODLINE TUBING FJK REYNOSA MANUFACTURING NA 10JR01019

    Patients

    Seq Age Sex Outcome Treatment
    1 NA