BEUDAMED
    FDA Adverse Event Other Summary report: N

    C-SERIES

    MDR report key: 1032953 · Received April 23, 2008

    Report

    Report Number
    2026095-2008-00048
    Event Type
    Other
    Date Received
    April 23, 2008
    Date of Event
    March 24, 2008
    Report Date
    March 25, 2008
    Manufacturer
    I-FLOW CORP.
    Product Code
    MEB
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    PHARMACIST

    Narratives

    Additional Manufacturer Narrative · 1

    EVAL SUMMARY: THE SAMPLE WAS NOT RECEIVED FOR EVAL AND INVESTIGATION, BUT IS EXPECTED. THE INFO CONTAINED HEREIN IS BASED ON THE INFO PROVIDED BY THE INITIAL REPORTER. THE PT RETURNED THE PUMP TO THE PHARMACY STATING IT HAD FINISHED 24 HRS EARLY. NO ADVERSE EVENT OCCURRED. WITHOUT THE ACTUAL DEVICE, THE INVESTIGATION IS LIMITED TO DOCUMENTATION AND RETAINED PRODUCT. THE DIRECTIONS FOR USE INDICATE THAT A PUMP FILLED TO A FILL VOLUME OF 203 WILL RUN FOR APPROX 7.5 DAYS. THERE IS A FLOW RATE ACCURACY OF +/-15%. WITH THIS INFO, THE PUMP APPEARS TO HAVE RUN WITHIN THE ESTIMATED TIMEFRAME. THE DEVICE HISTORY RECORD WAS REVIEWED FOR LOT 742711, AND ALL MFG OPERATIONS WERE FOUND TO BE WITHIN SPEC. A REVIEW OF LOT HISTORY FOUND NO OTHER FAST FLOW COMPLAINTS FOR LOT 742711. IN ADDITION, RETAIN SAMPLES FROM LOT 742711 WERE TESTED. THE PUMPS WERE FILLED WITH NORMAL SALINE SOLUTION TO THE NOMINAL FILL VOLUME OF 270 ML AND A FLOW RATE ACCURACY TEST WAS PERFORMED. THE FLOW ACCURACY TEST RESULTS WERE FOUND TO BE WITHIN SPEC. WHEN ADD'L INFO THAT IS PERTINENT TO THIS EVENT BECOMES AVAIL, I-FLOW WILL SUBMIT A F/U REPORT.

    Description of Event or Problem · 1

    PUMP INFUSED TOO QUICKLY (EMPTIED IN 6 DAYS INSTEAD OF 7 DAYS). FILL VOLUME 203ML.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 C-SERIES INFUSION PUMP MEB I-FLOW CORP. 270010 742711

    Patients

    Seq Age Sex Outcome Treatment
    1 Other