BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INFUSOMAT SPACE

    MDR report key: 5697582 · Received June 3, 2016

    Report

    Report Number
    9610825-2016-00342
    Event Type
    Malfunction
    Date Received
    June 3, 2016
    Date of Event
    May 19, 2016
    Report Date
    May 19, 2016
    Manufacturer
    B. BRAUN MELSUNGEN AG
    Product Code
    FRN
    PMA / PMN Number
    K062700
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 0

    EXEMPTION NUMBER E2011009. BRAUN MEDICAL INC. IS SUBMITTING A SINGLE REPORT ON BEHALF OF B. BRAUN MELSUNGEN (THE MANUFACTURER), AND B. BRAUN MEDICAL INC. (THE IMPORTER). THE REPORT WAS IDENTIFIED AS B. BRAUN MEDICAL INC. INTERNAL REPORT# (B)(4). THE ACTUAL DEVICE INVOLVED HAS NOT BEEN RECEIVED FOR EVALUATION AND THE INVESTIGATION IS ONGOING AT THIS TIME. A FOLLOW-UP REPORT WILL BE PROVIDED AFTER THE EXAMINATION RESULTS ARE AVAILABLE.

    Additional Manufacturer Narrative · 0

    EXEMPTION NUMBER E2011009. B. BRAUN MEDICAL INC. IS SUBMITTING A SINGLE REPORT ON BEHALF OF B. BRAUN MELSUNGEN (THE MANUFACTURER), AND B. BRAUN MEDICAL INC. (THE IMPORTER). THIS REPORT HAS BEEN IDENTIFIED AS B. BRAUN MEDICAL INTERNAL REPORT NUMBER (B)(4). THE PUMP WAS RETURNED TO OUR CONTRACTED SERVICE PROVIDER. THE PUMP HAD A FLASHING BLUE LIGHT, AND WAS NOT CONNECTING TO HIBASE. THE PUMP LOG COULD NOT BE DOWNLOADED. THE MOTHER BOARD OF THE UNIT WAS REPLACED, AND THE DEVICE PASSED ALL TECHNICAL SAFETY CHECKS AFTER COMPLETION OF THE SERVICE ACTIVITY. IF ADDITIONAL PERTINENT INFORMATION BECOMES AVAILABLE, A FOLLOW UP REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 0

    AS REPORTED BY USER FACILITY: EVENT: THE CUSTOMER REPORTED: THE PUMP WOULD NOT ALLOW INFUSION OF SECOND BAG. ONE (1) BAG INFUSED, SECOND BAG HUNG, WHEN NURSE WENT BACK TO CHECK, IT WAS COMPLETELY FULL, NO ALARMING. THE PUMP WAS CHANGED TO COMPLETE INFUSION. "I THINK IT WAS USER ERROR" WHEN I WENT TO ACCESS PUMP HISTORY VIA (B)(6), I WAS UNABLE TO ACCESS IT." NO PATIENT INJURY REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    352646 INFUSOMAT SPACE INFUSION PUMP FRN B. BRAUN MELSUNGEN AG

    Patients

    Seq Age Sex Outcome Treatment
    1