BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EASYPUMP: 100 ML, 2 ML/HR

    MDR report key: 3023804 · Received March 26, 2013

    Report

    Report Number
    2026095-2013-00048
    Event Type
    Injury
    Date Received
    March 26, 2013
    Date of Event
    January 30, 2013
    Report Date
    February 25, 2013
    Manufacturer
    I-FLOW CORP.
    Product Code
    MEB
    PMA / PMN Number
    K052117
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    METHOD: THE EVALUATION OF THE PUMP IS ANTICIPATED, BUT NOT YET BEGUN. RESULTS: THE DEVICE IS PENDING EVALUATION AND TESTING AT THIS TIME. CONCLUSIONS: A FOLLOW-UP REPORT WILL BE FILED WHEN THE INVESTIGATION IS COMPLETE. I-FLOW PROVIDES A "CAUTION" IN ITS DFU (EASYPUMP LT) WHICH STATES 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 EASYPUMP LT FLOW RESTRICTOR (LOCATED DISTAL TO THE FILTER) SHOULD BE CLOSE TO, OR IN DIRECT CONTACT WITH THE SKIN (31 DEGREE CENTIGRADE/88 DEGREE F) AND THE TUBING SHOULD BE UNDER THE PTS 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%. INFO FROM THIS INCIDENT WILL BE INCLUDED IN OUR PRODUCT COMPLAINT AND MDR TREND REPORTING SYSTEM. ADD'L INVESTIGATION MAY ARISE FROM ONGOING ANALYSIS, TREND INFO, OR OTHER ANALYSIS AS APPROPRIATE.

    Description of Event or Problem · 1

    DRUG/DILUENT: 5FU 4700MG. FILL VOLUME: 100 ML. FLOW RATE: 2 ML/HR. PROCEDURE: CHEMOTHERAPY. CATHPLACE: UNK. B. BRAUN REPORTED A FAST FLOW, THE PUMP INFUSED IN 26 HOURS INSTEAD OF 48 HOURS. CLINICAL ADVERSE EFFECTS REPORTED WERE ABDOMINAL PAIN, ASTHENIA, AND EXTREME ANXIETY. PT'S REPORTED CONDITION IS BETTER. START DATE AND TIME OF INFUSION: (B)(6) 2013 AT 4:00 PM. END DATE AND TIME OF INFUSION: (B)(6) 2013 AT 6:00 AM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    123350 EASYPUMP: 100 ML, 2 ML/HR ELASTOMERIC PUMP MEB I-FLOW CORP. 04434370 0200531684

    Patients

    Seq Age Sex Outcome Treatment
    1