BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COMBISET WITH BVM

    MDR report key: 1993309 · Received December 30, 2010

    Report

    Report Number
    8030665-2010-00117
    Event Type
    Malfunction
    Date Received
    December 30, 2010
    Date of Event
    November 29, 2010
    Report Date
    December 30, 2010
    Manufacturer
    REYNOSA MANUFACTURING
    Product Code
    FJK
    PMA / PMN Number
    K962081
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SD, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    A HEMODIALYSIS USER FACILITY HAS REPORTED HAVING ISSUE WITH THE ARTERIAL BLOOD CHAMBER THE TUBING IS TWISTED BELOW THE CUVETTE. THE FACILITY HAS BEEN CONTACTED. IT WAS CONFIRMED OF A REPORT OF ARTERIAL TUBING TWIST OR KINK ON THE ARTERIAL LINE OF THIS BLOODLINE. REPORTEDLY THE INCIDENT OCCURRED WHILE PRIMING. THE MACHINE ALARMED. THESE LINES WERE CHANGED OUT PRIOR TO THE START OF THE DIALYSIS TREATMENT. A SAMPLE IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COMBISET WITH BVM HEMODIALYSIS BLOODLINES FJK REYNOSA MANUFACTURING NA 10ER01251

    Patients

    Seq Age Sex Outcome Treatment
    1 NA