BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOMEPUMP ECLIPSE: 400ML, 100ML/HR

    MDR report key: 2958198 · Received February 6, 2013

    Report

    Report Number
    2026095-2013-00027
    Event Type
    Malfunction
    Date Received
    February 6, 2013
    Date of Event
    January 7, 2013
    Manufacturer
    I-FLOW, LLC.
    Product Code
    MEB
    PMA / PMN Number
    K052117
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    PHARMACIST

    Narratives

    Additional Manufacturer Narrative · 1

    METHOD: ACTUAL PUMP INVOLVED IN INCIDENT WAS RECEIVED. RESULTS: THE EVALUATION OF THE PUMP IS ANTICIPATED, BUT NOT YET BEGUN. IN THE REPORTED INFORMATION IT APPEARS THAT THE PUMP WAS UNDER FILLED (225ML) BY THE PHARMACIST, THE NOMINAL FILL VOLUME OF THE PUMP MODEL E401000 IS 400ML. CONCLUSIONS: I-FLOW PROVIDES A CAUTION IN ITS DFU WHICH STATES: ACTUAL INFUSION TIMES MAY VARY DUE TO THE FOLLOWING: CAUTIONS: ACTUAL INFUSION TIMES MAY VARY DUE TO THE FOLLOWING: FILLING THE PUMP LESS THAN NOMINAL RESULTS IN FASTER FLOW RATE. FILLING THE PUMP MORE THAN NOMINAL RESULTS IN SLOWER FLOW RATE. TEMPERATURE WILL AFFECT SOLUTION VISCOSITY, RESULTING IN SHORTER OR LONGER DELIVERY TIME. THE HOMEPUMP ECLIPSE IS DESIGNED TO BE USED AT ROOM TEMPERATURE (20 DEGREES C/68 DEGREES F). IF THE HOMEPUMP ECLIPSE OR ITS TUBING IS AT 25 DEGREES C/78 DEGREES F, THE FLOW RATE WILL INCREASE BY APPROX 14% ABOVE ITS NOMINAL RATE; AT 15 DEGREES C/60 DEGREES F, THE FLOW RATE WILL DECREASE APPROXIMATELY 12% BELOW ITS NOMINAL RATE. THE HOMEPUMP ECLIPSE AND TUBING SHOULD BE WORN OUTSIDE THE CLOTHING. THE HOMEPUMP ECLIPSE MUST BE FILLED FOUR HOURS PRIOR TO ADMINISTRATION TO INFUSE AT THE LABELED FLOW RATE. IF THE HOMEPUMP ECLIPSE IS USED IMMEDIATELY AFTER FILLING, FLOW RATE MAY INCREASE BY UP TO 50%. A FOLLOW-UP REPORT WILL BE FILED WHEN THE INVESTIGATION HAS BEEN COMPLETED. INFORMATION FROM THIS INCIDENT WILL BE INCLUDED IN OUR PRODUCT COMPLAINT AND MDR TREND REPORTING SYSTEM. ADDITIONAL INVESTIGATION MAY ARISE FROM ONGOING ANALYSIS, TREND INFORMATION, OR OTHER ANALYSIS AS APPROPRIATE.

    Description of Event or Problem · 1

    DRUG/DILUENT: SALINE. FILL VOLUME: 225 ML. FLOW RATE: 100ML/HR. PT CONTACT: NO. PHARMACIST REPORTED A FAST FLOW ISSUE. SHE FILLED THE PUMP WITH 225ML SALINE AND RAN IT. SHE EXPECTED THE PUMP TO RUN ABOUT 2 HOURS AND 15 MINUTES. INSTEAD IT RAN FOR ABOUT 95 MINUTES. REFERENCE: 2026095-2013-00028 (13-00031) FOR SECOND PUMP ISSUE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    49701 HOMEPUMP ECLIPSE: 400ML, 100ML/HR ELASTOMERIC PUMP MEB I-FLOW, LLC. E401000 0008011929

    Patients

    Seq Age Sex Outcome Treatment
    1