BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INFUSOMAT SPACE - US VERSION

    MDR report key: 3769918 · Received April 17, 2014

    Report

    Report Number
    2523676-2014-00108
    Event Type
    Malfunction
    Date Received
    April 17, 2014
    Date of Event
    October 21, 2013
    Report Date
    March 21, 2014
    Manufacturer
    B. BRAUN MELSUNGEN AG
    Product Code
    FRN
    Product Problem
    Yes
    Report Source
    Distributor report
    Reporter Location
    MO, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    AS REPORTED BY THE USER FACILITY: INTEGRILIN GTT INFUSING BY PUMP #JNE 4183 WAS SET AT 14.94 ML/HR. PUMP RECORD SHOWED RATE AT 14.94, AMT INFUSED WAS 36.44 ML AND INFUSION TIME WAS 2 HR AND 24 MINS. A 100 ML OF INTEGRILIN BOTTLE WAS EMPTY. (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    236354 INFUSOMAT SPACE - US VERSION INFUSION PUMP FRN B. BRAUN MELSUNGEN AG NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK