BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COMBISET WITH BVM

    MDR report key: 1933868 · Received December 11, 2010

    Report

    Report Number
    8030665-2010-00050
    Event Type
    Malfunction
    Date Received
    December 11, 2010
    Date of Event
    October 13, 2010
    Report Date
    November 12, 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
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE MFR IS REVIEWING THE DESIGN HISTORY FILE MFG AND LOT RECORDS FOR THIS PRODUCT. IN ADDITION THE MFR HAS MADE VISITS TO THIS CUSTOMER FACILITY TO OBSERVE THE CLINICAL PRACTICE AND COLLECT ADDITIONAL 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

    ON (B)(6), 2010, A REPORT WAS RECEIVED FROM (B)(6) OF A POSSIBLE BLOODLINE TUBING KINK ON THE ARTERIAL LINE OF THE BVM COMBISET BLOODLINE. REPORTEDLY, THE KINK WAS NOTED TO BE AT THE CUVETTE ON THE ARTERIAL SIDE OF THE BLOODLINE. IT WAS DETECTED WHEN REMOVING THE LINES FROM THE PACKAGING 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 10HR01083

    Patients

    Seq Age Sex Outcome Treatment
    1 NA