BEUDAMED
    FDA Adverse Event Other Summary report: N

    VISTA BASIC - IFVB

    MDR report key: 3111465 · Received April 30, 2013

    Report

    Report Number
    2523676-2013-00114
    Event Type
    Other
    Date Received
    April 30, 2013
    Report Date
    April 3, 2013
    Manufacturer
    B. BRAUN MELSUNGEN AG
    Product Code
    FRN
    Product Problem
    Yes
    Report Source
    Distributor report
    Reporter Location
    ME, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Description of Event or Problem · 1

    AS REPORTED BY THE USER FACILITY: EVENT: BLOOD FROM DIALYSIS UNIT BACKING UP LINE DURING HEMODIALYSIS. FACILITY IS ADMINISTERING AN ANTIBIOTIC (EITHER VANCOMYCIN OR GENTAMYCIN) DURING VENOUS CHAMBER OF HEMODIALYSIS MACHINE; INFUSING VIA VISTA BASIC PUMP. THE PUMP IS SET ON HIGH OCCLUSION PRESSURE. BLOOD FROM DIALYSIS MACHINE IS BACKING UP LINE INTO BAG; NO ALARM IS SOUNDING. ALL OTHER VISA BASIC PUMPS ARE SET UP THE SAME WAY AND ARE NOT HAVING ANY INFUSION ISSUES. REF MFR REPORT: 9610825-2013-00114.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    188716 VISTA BASIC - IFVB INFUSION PUMP FRN B. BRAUN MELSUNGEN AG NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 * Other