BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOMEPUMP ECLIPSE: 400ML, 100ML

    MDR report key: 3853252 · Received April 3, 2014

    Report

    Report Number
    2026095-2014-00038
    Event Type
    Malfunction
    Date Received
    April 3, 2014
    Date of Event
    February 28, 2014
    Report Date
    March 10, 2014
    Manufacturer
    I-FLOW, LLC
    Product Code
    MEB
    PMA / PMN Number
    K052117
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    METHOD: THE DEVICE HAS BEEN RETURNED FOR AN EVALUATION AND INVESTIGATION. A VISUAL INVESTIGATION WAS PERFORMED ON THE RETURNED UNIT AND A REVIEW OF THE DEVICE HISTORY RECORDS (DHR) IS IN PROGRESS FOR THE REPORTED LOT NUMBER. RESULTS: AT THIS TIME THE EVALUATION IS STILL IN PROGRESS. RESULTS WILL BE PROVIDED ONCE COMPLETED. CONCLUSIONS: THE INVESTIGATION AND EVALUATION ARE ONGOING, ONCE COMPLETED A FOLLOW-UP REPORT WILL BE SUBMITTED. INFO FROM THIS INCIDENT WILL BE INCLUDED IN OUR PRODUCT COMPLAINT AND MDR TREND REPORTING SYSTEM. ADDITIONAL INVESTIGATION MAY ARISE FROM ONGOING ANALYSIS, TREND INFO, OR OTHER ANALYSIS AS APPROPRIATE.

    Description of Event or Problem · 1

    DRUG/DILUENT: SOLUMEDROL WITH 5% GLUCOSE. FILL VOLUME: 250ML. FLOW RATE: 100ML/HR. PROCEDURE: IV THERAPY. CATHPLACE: PERIPHERAL IV. DATE OF SURGERY: (B)(6) 2014. THE CUSTOMER REPORTED A FAST FLOW WHILE USING AN I-FLOW HOMEPUMP 400MLX100ML, FILLED WITH 1G SOLUMEDROL IN 250ML'S OF 5% GLUCOSE SOLUTION THAT WAS CONNECTED TO A PT. THE SOLUTION WAS ADMINISTERED IN 1 HOUR & 20 MINUTES INSTEAD OF 2 HOURS & 30 MINUTES. THE INFUSION WAS VIA A PERIPHERAL IV. THE PUMP WAS PLACED IN THE FANNY PACK AROUND THE PT'S WAIST. THE INFUSION TEMPERATURE WAS ABOUT 24 DEGREES CELSIUS. INFUSION STARTED (B)(6) 2014 AT 9AM OR 10AM. INFUSION ENDED (B)(6) 2014 AT 10:30AM. INCIDENT NOTICED AT (B)(6) 2014 AT 10:30AM. THE PUMP WAS EMPTIED AT THE END OF THE INFUSION. SAMPLE WILL BE RETURNED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    203083 HOMEPUMP ECLIPSE: 400ML, 100ML ELASTOMERIC PUMP MEB I-FLOW, LLC E401000-10 0200974832

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR