BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COMBISET WITH BVM

    MDR report key: 1922627 · Received November 12, 2010

    Report

    Report Number
    8030665-2010-00044
    Event Type
    Malfunction
    Date Received
    November 12, 2010
    Date of Event
    October 1, 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 MANUFACTURER IS REVIEWING THE DESIGN HISTORY FILE AND MANUFACTURING RECORDS FOR THIS PRODUCT. IN ADDITION THE MANUFACTURER HAS MADE VISITS TO THIS CUSTOMER FACILITY TO OBSERVE THE CLINICAL PRACTICE AND COLLECT INFORMATION 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 ON THE BVM COMBISET BLOODLINE. ADDITIONAL INFORMATION RECEIVED ON OCTOBER 15, 2010, REPORTED THAT THE INCIDENT OCCURRED WHILE A PATIENT WAS RECEIVING HEMODIALYSIS TREATMENT WHEN A NURSE NOTICED THAT THE ARTERIAL LINE WAS KINKED (BENT) AS IT EXITED THE BLOOD VOLUME MODULE (BVM) ON THE MACHINE. THE NURSE THEN TAPED THE LINE TO PREVENT THE KINKING. ALTHOUGH THERE WAS PATIENT INVOLVEMENT THERE WAS NO INJURY TO THE PATIENT AND NO MEDICAL INTERVENTION REQUIRED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 NA