BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EASY PUMP

    MDR report key: 2043272 · Received February 25, 2011

    Report

    Report Number
    2026095-2011-00057
    Event Type
    Malfunction
    Date Received
    February 25, 2011
    Date of Event
    May 28, 2008
    Report Date
    December 2, 2008
    Manufacturer
    I-FLOW CORP
    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 DEVICE INVOLVED IN THIS INCIDENT WAS DISCARDED BY THE CUSTOMER, THEREFORE, OUR RESULTS AND CONCLUSION ARE BASED ON THE INFORMATION THAT WAS GIVEN TO I-FLOW BY THE INITIAL REPORTER. THE DIRECTIONS FOR USE (DFU) (1303046, REV. E) CONTAINS A CAUTION FOR UNDERFILLING THE PUMP: "CAUTIONS: ACTUAL INFUSION TIMES MAY VARY DUE TO THE FOLLOWING: FILLING THE PUMP LESS THAN NOMINAL RESULTS IN FASTER FLOW RATE." THE DEVICE HISTORY RECORD WAS REVIEWED AND ALL MANUFACTURING OPERATIONS WERE FOUND TO BE WITHIN SPECIFICATION. A REVIEW OF LOT 772216 HISTORY FOUND NO OTHER FLOW RATE COMPLAINTS FOR THIS LOT. RESULTS: ALTHOUGH THE DEVICE WAS NOT RETURNED FOR INVESTIGATION AND EVALUATION. FROM INFORMATION PROVIDED, THE FILL VOLUME OF THE PUMP WAS 240ML. THE TIMEFRAME REPORTED FOR INFUSION OF 38 HOURS IS WITHIN THE EXPECTED LIMIT FOR A 240ML FILL VOLUME AT 5ML/HR FLOW. THE DELIVERY TIMES PROVIDED IN THE DFU ARE APPROXIMATE WHEN PUMP IS FILLED TO A VOLUME OTHER THAN NOMINAL.

    Description of Event or Problem · 1

    (DRUG/DILUENT: 5FU). FLOW RATE TOO FAST. THE PUMP EMPTIED AT 38.5 HOURS AND WAS EXPECTED TO LAST 48 HOURS. PUMP WAS FILLED AT 5:30 P.M. (B)(6) 2008 AND EMPTY AT (B)(6) 2008, 8:00 A.M. FILL VOLUME 240 ML. PER DFU: NOMINAL FILL VOLUME: 270ML AND NOMINAL FLOW RATE: 5ML/HR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EASY PUMP ELASTOMERIC PUMP MEB I-FLOW CORP LT 270-54 772216

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK