BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EASYPUMP: LT 270-132: 270ML, 2ML/HR

    MDR report key: 2903988 · Received January 3, 2013

    Report

    Report Number
    2026095-2013-00003
    Event Type
    Malfunction
    Date Received
    January 3, 2013
    Date of Event
    November 14, 2012
    Report Date
    December 7, 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: THE SAMPLE HAS BEEN RECEIVED BY THE REPORTER FOR INSPECTION AND EVAL. RESULTS: THE DEVICE EVAL IS ANTICIPATED, BUT NOT YET BEGUN. CONCLUSIONS: A FOLLOW-UP REPORT WILL BE FILED WHEN THE INVESTIGATION HAS BEEN COMPLETED. A REVIEW OF THE DEVICE HISTORY RECORDS (DHR) WAS CONDUCTED FOR THE LOT NUMBER AND INCIDENT REPORTED. THE DEVICE PASSED ALL MANUFACTURING SPECIFICATIONS PRIOR TO RELEASE. I-FLOW PROVIDES A CAUTION IN ITS DFU (1303046G) 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 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 (21 DEGREES C/88 DEGREES F) AND THE TUBING SHOULD BE UNDER THE PT'S CLOTHING. IF THE EASYPUMP LT IS USED WITH THE FLOW RESTRICTOR AT ROOM TEMPERATURE (20 DEGREES C/68 DEGREES F), DELIVERY TIME WILL INCREASE APPROXIMATELY BY 25%. THE EASYPUMP LT DELIVERY SHOULD BE STARTED WITHIN 8 HOURS PRIOR TO STARTING INFUSION MAY RESULT IN A 10% LONGER DELIVERY TIME. IF THE EASYPUMP UNIT NEEDS TO BE STORED IN THE REFRIGERATOR OR FREEZER, ALLOW THE UNIT TO WARM TO ROOM TEMPERATURE BEFORE USING. DELIVERY TIME INFORMATION, FOR THE REQUIRED INFO TO MEET ROOM TEMPERATURE. NOTE: DELIVERY TIME CAN INCREASE SIGNIFICANTLY AS A RESULT OF EXTENDED STORAGE TIME. THE EASYPUMP NOMINAL FLOW RATES ARE BASED ON THE USE OF NORMAL SALINE AS THE DILUENT. ADDITION OF ANY DRUG OR USE OF ANOTHER DILUENT MAY CHANGE VISCOSITY AND RESULT IN INCREASED OR DECREASED FLOW RATE. USE OF 5% DEXTROSE WILL RESULT IN 10% LONGER DELIVERY TIME. INFO FROM THIS INCIDENT WILL BE INCLUDED IN OUR PRODUCTS COMPLAINT AND MDR TREND REPORTING SYSTEM.

    Description of Event or Problem · 1

    DRUG/DILUENT: 5 FU. FILL VOLUME: 325 ML. FLOW RATE: UNK. PROCEDURE: UNK. CATHPLACE: UNK. (B)(6). B. BRAUN REPORTED A FAST FLOW, THE PUMP INFUSED IN THREE DAYS INSTEAD OF SEVEN DAYS. START DATE: (B)(4) 2012, END DATE: (B)(4) 2012. ADVERSE EVENT: UNKNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    3609 EASYPUMP: LT 270-132: 270ML, 2ML/HR ELASTOMERIC PUMP MEB I-FLOW, LLC. 04434376 0A2655

    Patients

    Seq Age Sex Outcome Treatment
    1 NP