BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EASYPUMP: LT 270-24: 270ML, 10ML/HR

    MDR report key: 2801532 · Received October 18, 2012

    Report

    Report Number
    2026095-2012-00255
    Event Type
    Malfunction
    Date Received
    October 18, 2012
    Date of Event
    September 1, 2012
    Report Date
    September 20, 2012
    Manufacturer
    I-FLOW, LLC
    Product Code
    MEB
    PMA / PMN Number
    K052117
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    METHOD: AT THE TIME OF THIS REPORT, THE SAMPLE HAS NOT YET BEEN RECEIVED, BUT WAS REPORTED TO BE AVAILABLE. RESULTS: THE SAMPLE WILL BE EVALUATED AND TESTED WHEN RECEIVED. A REVIEW OF THE DEVICE HISTORY RECORD (DHR) WAS CONDUCTED FOR THE LOT NUMBER PROVIDED, AND THE DEVICE PASSED ALL MANUFACTURING SPECIFICATIONS PRIOR TO RELEASE. CONCLUSIONS: A FOLLOW-UP REPORT WILL BE FILED WHEN THE INVESTIGATION HAS BEEN COMPLETED. I-FLOW PROVIDES A CAUTION ON IT'S DFU WHICH STATES THE FOLLOWING: 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 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 EASYPUMP LT FLOW RESTRICTOR (LOCATED DISTAL TO THE FILTER) SHOULD BE CLOSE TO, OR IN DIRECT CONTACT WITH THE SKIN (31 DEGREE C/88 DEGREE F) AND THE TUBING SHOULD BE UNDER THE PATIENT'S CLOTHING. IF THE EASYPUMP LT IS USED WITH THE FLOW RESTRICTOR AT ROOM TEMPERATURE (20 DEGREE C/68 DEGREE F), DELIVERY TIME WILL INCREASE APPROXIMATELY BY 25 PERCENT. 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: UNKNOWN. FILL VOLUME: UNKNOWN. FLOW RATE: UNKNOWN. PROCEDURE: UNKNOWN. CATHPLACE: UNKNOWN. HAD 39, (B)(6) REPORTED A FAST FLOW ISSUE AND THE PUMP INFUSED IN 20 HOURS INSTEAD OF 24 HOURS. ADVERSE EVENT IS UNKNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EASYPUMP: LT 270-24: 270ML, 10ML/HR ELASTOMERIC PUMP MEB I-FLOW, LLC 04434378 0200317339

    Patients

    Seq Age Sex Outcome Treatment
    1