BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VISTA BASIC - IFVB

    MDR report key: 3953568 · Received July 8, 2014

    Report

    Report Number
    2523676-2014-00265
    Event Type
    Malfunction
    Date Received
    July 8, 2014
    Report Date
    June 24, 2014
    Manufacturer
    B. BRAUN MELSUNGEN AG
    Product Code
    FRN
    Product Problem
    Yes
    Report Source
    Distributor report
    Reporter Location
    MO, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Description of Event or Problem · 1

    AS REPORTED BY THE USER FACILITY: CUSTOMER REPORTED INFUSION OF TRASTUZUMAB TOTAL VOLUME 256.6 ML OVER 30 MINUTES. COLUMN OF AIR TO 6 INCHES BELOW PUMP, NO AIR IN LINE ALARM. PUMP DID ALARM INFUSION COMPLETE. NO PATIENT INJURY. MFR REPORT #: 9610825-2014-00265.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    398240 VISTA BASIC - IFVB INFUSION PUMP FRN B. BRAUN MELSUNGEN AG NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK