BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COMBISET WITH BVM

    MDR report key: 1930167 · Received November 22, 2010

    Report

    Report Number
    8030665-2010-00088
    Event Type
    Malfunction
    Date Received
    November 22, 2010
    Date of Event
    November 5, 2010
    Report Date
    November 22, 2010
    Manufacturer
    REYNOSA MANUFACTURING
    Product Code
    FJK
    PMA / PMN Number
    K962081
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    A REPORT HAS BEEN RECEIVED OF A POSSIBLE BLOODLINE TUBING KINK ON THE ARTERIAL LINE OF THE BVM COMBISET BLOODLINE. REPORTEDLY THE INCIDENT OCCURED WHILE A PATIENT WAS RECEIVING HEMODIALYSIS TREATMENT WHEN A NURSE NOTICED THAT A KINK OCCURRED BEHIND THE BVM DOOR AT THE POINT OF WHERE THE LINE CONNECTS TO THE CUVETTE. ALSO HAD INCIDENTS OF KINKING AT THE SHORT TUBING SEGMENT LEADING FROM THE TOP OF THE CUVETTE INTO CHAMBER. PRODUCT APPEARS NORMAL DURING SET UP BUT WHEN IT WARMS UP KINKING OCCURS. CLOTTING DID OCCUR. ALTHOUGH THERE WAS PATIENT INVOLVEMENT THERE WAS NO INJURY TO THE PATIENT BUT CAUSES RE NEEDLING AND A DELAY IN 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 10LR01061

    Patients

    Seq Age Sex Outcome Treatment
    1 NA