BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DIALOG A + HE/BIC

    MDR report key: 5354537 · Received January 8, 2016

    Report

    Report Number
    3002879653-2015-00015
    Event Type
    Malfunction
    Date Received
    January 8, 2016
    Date of Event
    December 9, 2015
    Report Date
    December 18, 2015
    Manufacturer
    B. BRAUN AVITUM AG - MELSUNGEN
    Product Code
    FKJ
    PMA / PMN Number
    K083460
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 0

    EXEMPTION NUMBER E2015012. B.BRAUN MEDICAL INC (IMPORTER) IS SUBMITTING THIS REPORT ON BEHALF OF B.BRAUN AVITUM AG (MANUFACTURER). THIS REPORT HAS BEEN IDENTIFIED AS B.BRAUN MEDICAL INTERNAL REPORT NUMBER (B)(4). CORRECTION - TYPOGRAPHICAL ERROR : CHANGE FROM :UF/IMPORTER REPORT #: (B)(4).

    Additional Manufacturer Narrative · 0

    EXEMPTION NUMBER E2015012. B.BRAUN MEDICAL INC (IMPORTER) IS SUBMITTING THIS REPORT ON BEHALF OF B.BRAUN AVITUM AG (MANUFACTURER). THIS REPORT HAS BEEN IDENTIFIED AS B.BRAUN MEDICAL INTERNAL REPORT NUMBER (B)(4). IN A FOLLOW UP WITH THE FACILITY, IT WAS COMMUNICATED THAT THE CUSTOMER'S BIOMED TECHNICIAN RAN TWO SIMULATED THERAPIES WITH NO DEVIATIONS TO THE UF RESULT. BASED ON THIS, THE TECHNICIAN STATED THAT HE DID NOT THINK IT WAS A MACHINE PROBLEM. ADDITIONALLY, THE NURSE MANAGER COMMUNICATED THAT NO MALFUNCTIONS WERE NOTED; NO UNUSUAL ALARMS NOTED IN DOCUMENTATION. THE INVESTIGATION INTO THE REPORTED EVENT IS ON GOING AT THIS TIME. A FOLLOW UP REPORT WILL BE PROVIDED WHEN THE RESULTS OF THE EVALUATION BECOME AVAILABLE.

    Description of Event or Problem · 0

    AS REPORTED BY THE USER FACILITY: EVENT #2: CUSTOMER CALLED REPORTING AN INCIDENT RELATED TO ULTRIFILTATION PROBLEMS WITH THE MACHINE. THE CUSTOMER HAS RETRIEVED TRENDS FROM 4 PATIENT RUNS THAT HAVE REPORTED PROBLEMS. THE PATIENTS COMPLAINED OF CRAMPING. EMS WAS NOT REQUIRED ON ALL 4 ACCOUNTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    14057 DIALOG A + HE/BIC HEMODIALYSIS SYSTEM FKJ B. BRAUN AVITUM AG - MELSUNGEN N/A N/A

    Patients

    Seq Age Sex Outcome Treatment
    1