BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 2837686 · Received November 7, 2012

    Report

    Report Number
    2026095-2012-00271
    Event Type
    Malfunction
    Date Received
    November 7, 2012
    Date of Event
    September 13, 2012
    Report Date
    October 9, 2012
    Manufacturer
    I-FLOW
    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 NOT YET BEEN RECEIVED, BUT WAS REPORTED TO BE AVAILABLE. RESULTS - THE SAMPLE WILL BE EVALUATED AND TESTED WHEN RECEIVED. CONCLUSIONS: ACCORDING TO THE FILL VOLUME THAT HAS BEEN REPORTED, (192ML) IT APPEARS THAT THE DEVICE WAS UNDER FILLED. THE NOMINAL FILL VOLUME OF THIS REPORTED DEVICE IS 270ML. I-FLOW PROVIDES A "CAUTION" IN IT'S DFU WHICH STATES THE FOLLOWING: (EASYPUMP LT) (1303046G/DFU). 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 DEGREES CELSIUS/88 DEGREES FAHRENHEIT) AND THE TUBING SHOULD BE UNDER THE PATIENTS CLOTHING. IF THE EASYPUMP LT IS USED WITH THE FLOW RESTRICTOR AT ROOM TEMPERATURE (20 DEGREES CELSIUS/68 DEGREES FAHRENHEIT), DELIVERY TIME WILL INCREASE APPROXIMATELY BY 25. 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.

    Description of Event or Problem · 1

    DRUG/DILUENT: 5FU/NACL 0.9%. FILL VOLUME: 192 ML, FLOW RATE: UNKNOWN, PROCEDURE: CHEMOTHERAPY, CATHPLACE: UNKNOWN. SANTELYS PERFUSION, LOOS. B. BRAUN IN (B)(6) REPORTED A FAST FLOW AND THAT THE PUMP ENDED 30 HOURS AND 30 MINUTES EARLIER THAN THE FORCAST INFUSION TIME. ADVERSE EVENT IS UNKNOWN. START OF INFUSION: (B)(6) 2012 AT 4:30PM. END OF INFUSION: (B)(6) 2012 AT 9:30AM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LT 270-132: 270 ML, 2 ML/HR ELASTOMERIC PUMP MEB I-FLOW 04434376 172101

    Patients

    Seq Age Sex Outcome Treatment
    1