BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COMBISET WITH BVM

    MDR report key: 1931181 · Received November 16, 2010

    Report

    Report Number
    8030665-2010-00055
    Event Type
    Malfunction
    Date Received
    November 16, 2010
    Date of Event
    October 25, 2010
    Report Date
    November 16, 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 MANUFACTURER IS REVIEWING THE DESIGN HISTORY FILE AND THE LOT AND MANUFACTURING RECORDS FOR THIS PRODUCT. IN ADDITION, THE MANUFACTURER HAS MADE VISITS TO THE CUSTOMER FACILITY TO OBSERVE THE CLINICAL PRACTICE AND COLLECT INFORMATION 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)(4) OF A POSSIBLE BLOODLINE TUBING KINK ON THE ARTERIAL LINE OF THE BVM COMBISET BLOODLINE. REPORTEDLY, THE INCIDENT OCCURRED WHILE A PATIENT WAS RECEIVING HEMODIALYSIS TREATMENT WHEN A NURSE NOTICED THAT A KINK OCCURRED WHERE THE TUBING COMES OUT OF THE BVM MODULE OPPOSITE TO THE SHORT SEGMENT. THE FACILITY ATTEMPTED TO MITIGATE BY PROPPING, TAPING OR CLAMPING THE LINE HOWEVER IT DID NOT ALWAYS WORK AND THE KINK RETURNED. ALTHOUGH THERE WAS PATIENT INVOLVEMENT THERE WAS NO INJURY TO THE PATIENT BUT CAUSES RE-NEEDLING AND A DELAY IN TREATMENT.

    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