BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COMBISET WITH BVM

    MDR report key: 3063302 · Received March 1, 2013

    Report

    Report Number
    8030665-2013-00125
    Event Type
    Malfunction
    Date Received
    March 1, 2013
    Date of Event
    February 4, 2013
    Report Date
    February 4, 2013
    Manufacturer
    REYNOSA MANUFACTURING
    Product Code
    FJK
    PMA / PMN Number
    96-2081
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE ACTUAL DEVICE WAS RETURNED TO THE MANUFACTURER FOR PHYSICAL EVALUATION AND THE COMPLAINT IS CONFIRMED. AN INVESTIGATION OF THE DEVICE MANUFACTURING RECORDS WAS CONDUCTED BY THE MANUFACTURER. THERE WERE NO DEVIATIONS OR NONCONFORMANCES DURING THE MANUFACTURING PROCESS. IN ADDITION, THE BATCH RECORD REVIEW CONFIRMED THE LABELING, MATERIAL, AND PROCESS CONTROLS WERE WITHIN SPECIFICATION.

    Description of Event or Problem · 1

    A HEMODIALYSIS USER FACILITY HAS REPORTED THAT DURING TREATMENT, THE NURSE NOTICED AIR BUBBLES ENTERING THE ARTERIAL LINE PROXIMAL TO THE BLOOD PUMP. THE NURSE OPENED THE BVM DOOR AND THE LINE FELL APART AT THAT LOCATION. THE TREATMENT WAS STOPPED. THE LINE WAS DISCARDED AND REPLACED BY NEW LINES AND THE TREATMENT WAS RESTARTED. PATIENT HAD NO ILL EFFECT. SAMPLE IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    90653 COMBISET WITH BVM HEMODIALYSIS BLOODLINE FJK REYNOSA MANUFACTURING 12PR01810

    Patients

    Seq Age Sex Outcome Treatment
    1