BEUDAMED
    FDA Adverse Event Other Summary report: N

    ECLIPE

    MDR report key: 1032954 · Received April 23, 2008

    Report

    Report Number
    2026095-2008-00049
    Event Type
    Other
    Date Received
    April 23, 2008
    Date of Event
    March 1, 2008
    Report Date
    March 25, 2008
    Manufacturer
    I-FLOW CORP.
    Product Code
    MEB
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    EVAL SUMMARY: THE SAMPLE WAS RECEIVED FOR EVAL AND INVESTIGATION. THE INFO CONTAINED HEREIN IS BASED ON THE INFO PROVIDED BY THE INITIAL REPORTER. THE RETURNED DEVICE IS CURRENTLY BEING TESTING. THE RESULTS WILL BE REPORTED UPON CONCLUSION. THE PT EXPERIENCED A HEADACHE, WHICH CAN BE THE EFFECT OF THE DRUG VANCOMYCIN, WHICH WAS DISPENSED BY THE PAIN PUMP. THE DEVICE HISTORY RECORD WAS REVIEWED FOR LOT 712092, AND ALL MFG OPERATIONS WERE FOUND TO BE WITHIN SPEC. A REVIEW OF LOT HISTORY FOUND NO OTHER FAST FLOW COMPLAINTS FOR LOT 712092. IN ADDITION, RETAIN SAMPLES FROM LOT 712092 ARE BEING TESTED. THE RESULTS WILL BE REPORTED UPON CONCLUSION. 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

    FAST FLOW. INFUSED IN 30 MINS. PT EXPERIENCED SPONTANEOUS HEADACHE. NO OTHER PROBLEMS REPORTED. FILL VOLUME 365 ML.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ECLIPE INFUSION PUMP MEB I-FLOW CORP. E502500 712092

    Patients

    Seq Age Sex Outcome Treatment
    1 Other