BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INFUSOMAT SPACE

    MDR report key: 2091361 · Received May 5, 2011

    Report

    Report Number
    2523676-2011-00039
    Event Type
    Malfunction
    Date Received
    May 5, 2011
    Date of Event
    April 7, 2011
    Report Date
    May 5, 2011
    Manufacturer
    B. BRAUN MEDICAL INC.
    Product Code
    FRN
    PMA / PMN Number
    K062699
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE PUMP WAS RETURNED TO BE EVALUATED. NO VISUAL MANUFACTURING ABNORMALITIES WERE NOTED. INITIAL EVALUATION REVEALED THERE WAS NO DAMAGE NOTED TO THE FREE FLOW CLIP. ALTHOUGH IT WAS REPORTED THE IV SET USED IN THE PUMP AT THE TIME THE INCIDENT OCCURRED WOULD BE RETURNED WITH THE PUMP FOR EVALUATION, THE IV SET WAS NOT RETURNED. AT THIS TIME THIS INCIDENT IS STILL UNDER INVESTIGATION, PENDING FURTHER PHYSICAL EVALUATION OF THE PUMP. A FOLLOW-UP REPORT WILL BE FILED WHEN ALL TESTING ON THE PUMP IS COMPLETED. ALL AVAILABLE INFO HAS BEEN FORWARDED TO THE ACTUAL MANUFACTURER FOR EVALUATION.

    Description of Event or Problem · 1

    AS REPORTED BY THE USER FACILITY: NURSE DISCONNECTED THE PT FROM THE PUMP - REMOVING THE IV TUBING FROM THE PT. IV TUBING WAS STILL HOOKED UP TO THE PUMP. THE FREE FLOW CLIP DISENGAGED ALLOWING THE FLUID TO FLOW. THE NURSE HAD THE PUMP IN HAND WHEN THE INCIDENT OCCURRED. PUMP WAS IMMEDIATELY SENT TO THE BIOMED DEPT. TYPE OF MEDICATION/DRUG: PROPOFOL. RATE & VOLUME: 5.04 ML PER HOUR. SMALL AMOUNT WAS REMAINING IN THE IV CONTAINER. IV SET WAS SAVED AND WILL BE RETURNED WITH THE PUMP. ADDITIONAL INFO PROVIDED BY THE FACILITY INDICATED THE NURSE DISCONNECTED THE PT FROM THE LINE AND REMOVED THE IV TUBING FROM THE PT. THE PUMP WAS TURNED OFF. THE SET WAS STILL IN THE PUMP AND THE SET CONTINUED TO FLOW A SMALL AMOUNT OF THE DRUG FROM THE IV CONTAINER. IT WAS REPORTED THE NURSE DID NOT CLAMP OFF THE SET, PRIOR TO REMOVING THE IV FROM THE PT. THE SET WAS NOT REMOVED FROM THE PUMP AND THE PUMP AND SET WERE RETURNED FOR EVALUATION. NO SETTINGS WERE CHANGED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INFUSOMAT SPACE INFUSION PUMP FRN B. BRAUN MEDICAL INC. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Other