BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EASYPUMP LT: 100-48: 100ML, 2ML/HR

    MDR report key: 2941532 · Received January 31, 2013

    Report

    Report Number
    2026095-2013-00025
    Event Type
    Malfunction
    Date Received
    January 31, 2013
    Date of Event
    November 1, 2012
    Report Date
    January 2, 2013
    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, SAMPLE HAD NOT BEEN REC'D, BUT WAS REPORTED TO BE AVAILABLE. RESULTS: A DHR PROCESS CANNOT BE PERFORMED W/O A LOT NUMBER. I-FLOW IS ATTEMPTING TO OBTAIN ADD'L INFO FROM OUR DISTRIBUTOR REGARDING PT CONTACT, ADVERSE EVENT AND PUMP INFO. CONCLUSIONS: THE SAMPLE WILL BE EVALUATED WHEN REC'D AND A F/U REPORT WILL BE FILED. I-FLOW PROVIDES A "CAUTION" IN ITS DFU (EASYPUMP LT) WHICH STATES THE FOLLOWING: ACTUAL INFUSION TIMES MAY VARY DUE TO THE FOLLOWING: FILLING THE PUMP LESS THAN NOMINAL RESULTS IN FASTER 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 DEGREES CELSIUS/88 DEGREES FAHRENHEIT) AND THE TUBING SHOULD BE UNDER THE PTS CLOTHING. IF THE EASYPUMP LT IS USED WITH THE FLOW RESTRICTOR AT ROOM TEMPERATURE (20 DEGREES CELSIUS/68 DEGREES FAHRENHEIT), DELIVERY TIME WILL INCREASE APPROX BY 25%. INFO FROM THIS INCIDENT HAS BEEN 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. FILL VOLUME: UNK. FLOW RATE: 2ML/HR. PROCEDURE: CHEMOTHERAPY. CATHPLACE: IV INFUSION. EVENT DATE: (B)(6) 2012 (DAY WAS NOT SPECIFIED). HOSPITAL (B)(6) REPORTED A FAST FLOW ISSUE. PT IS REPORTED TO HAVE EXPERIENCED ASTHENIA AFTER THE INCIDENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    42626 EASYPUMP LT: 100-48: 100ML, 2ML/HR ELASTOMERIC PUMP MEB I-FLOW, LLC 04434370 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1