BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INFUSOMAT SPACE - US VERSION

    MDR report key: 3111464 · Received April 30, 2013

    Report

    Report Number
    2523676-2013-00112
    Event Type
    Malfunction
    Date Received
    April 30, 2013
    Date of Event
    March 1, 2013
    Report Date
    April 1, 2013
    Manufacturer
    B. BRAUN MELSUNGEN AG
    Product Code
    FRN
    Product Problem
    Yes
    Report Source
    Distributor report
    Reporter Location
    CA, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Description of Event or Problem · 1

    AS REPORTED BY USER FACILITY: NURSE REPORTED TO BIOMED THAT PUMP UNDER INFUSED WHILE ON A PATIENT, BUT NO OTHER CLINICAL INFORMATION WAS GIVEN. LONG SHOWS UNDER INFUSION. DURING ACCURACY TESTING IN BIOMED DEPARTMENT PUMP ACTUALLY OVER INFUSED TWICE. PLEASE REFER MFR REF # 9610825-2013-00112.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    186004 INFUSOMAT SPACE - US VERSION INFUSION PUMP FRN B. BRAUN MELSUNGEN AG NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other