BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INFUSOMAT SPACE - US VERSION

    MDR report key: 3360465 · Received September 17, 2013

    Report

    Report Number
    2523676-2013-00273
    Event Type
    Malfunction
    Date Received
    September 17, 2013
    Date of Event
    March 6, 2013
    Report Date
    August 26, 2013
    Manufacturer
    B. BRAUN MELSUNGEN AGE
    Product Code
    FRN
    Product Problem
    Yes
    Report Source
    Distributor report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    AS REPORTED BY THE USER FACILITY: SERIAL #(B)(4), DATE OF OCCURRENCE: (B)(6) 2013. PUMP PROGRAMMED TO INFUSE "1CC/HR, DELIVERED 0.6CC." NO INFORMATION AS TO WHAT MEDICATION WAS INFUSING. NO PT INJURY REPORTED. REF MFR REPORT 9610825-2013-00273.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    468976 INFUSOMAT SPACE - US VERSION INFUSION PUMP FRN B. BRAUN MELSUNGEN AGE NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK