BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COMBISET WITH BVM

    MDR report key: 1930212 · Received November 18, 2010

    Report

    Report Number
    8030665-2010-00071
    Event Type
    Malfunction
    Date Received
    November 18, 2010
    Date of Event
    November 8, 2010
    Report Date
    November 18, 2010
    Manufacturer
    REYNOSA MANUFACTURING
    Product Code
    FJK
    PMA / PMN Number
    K962081
    Removal / Correction Number
    NA
    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 THE LOT AND MFG RECORDS FOR THIS PRODUCT. IN ADDITION, THE MFR HAS MADE VISITS TO THESE CLINICS TO OBSERVE THE CLINICAL PRACTICE AND COLLECT INFO THAT WILL BE HELPFUL TO THE INVESTIGATION. THE INVESTIGATION IS ONGOING AND A ROOT CAUSE HAS NOT YET BEEN DETERMINED AT THIS TIME.

    Description of Event or Problem · 1

    A REPORT HAS BEEN RECEIVED FROM (B)(6) OF A POSSIBLE BLOODLINE TUBING KINK ON THE ARTERIAL OF THE BVM COMBISET BLOODLINE. REPORTEDLY, THE KINK WAS NOTED TO BE POST CUVETTE ON THE ARTERIAL SIDE OF THE BLOODLINE. IT WAS DETECTED DURING PREP PRIOR TO THE INITIATION OF PT TREATMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COMBISET WITH BVM DIALYSIS BLOODLINE TUBING FJK REYNOSA MANUFACTURING NA 10LR01061

    Patients

    Seq Age Sex Outcome Treatment
    1 NA