BEUDAMED
    FDA Adverse Event Other Summary report: N

    ON-Q C-BLOC

    MDR report key: 1056641 · Received June 4, 2008

    Report

    Report Number
    2026095-2008-00061
    Event Type
    Other
    Date Received
    June 4, 2008
    Date of Event
    May 8, 2008
    Report Date
    May 8, 2008
    Manufacturer
    I-FLOW CORP.
    Product Code
    MEB
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    EVAL SUMMARY: THE SAMPLE HAS NOT BEEN RECEIVED FOR EVAL AND INVESTIGATION, ALTHOUGH REPORTED AS AVAILABLE. THE INFO CONTAINED HEREIN IS BASED ON THE INFO PROVIDED BY THE INITIAL REPORTER. THE REPORT STATED THAT A PUMP INFUSED TOO FAST, BUT THE PUMP MAY HAVE BEEN UNDERFILLED BY THE PHARMACY. NO ADVERSE EVENT OCCURRED, PER THE PHYSICIAN. WHEN THE PUMP IS RECEIVED, IT WILL BE EVALUATED. THE DEVICE HISTORY RECORD FOR LOT 812182 WAS REVIEWED, AND ALL MFG OPERATIONS WERE FOUND TO BE WITHIN SPEC. THE LOT HISTORY WAS REVIEWED AND THIS IS THE ONLY COMPLAINT OF A FAST FOR LOT 812182. IN ADDITION, RETAIN SAMPLES FROM LOT 812182 ARE BEING TESTED AND THE RESULTS WILL BE REPORTED IN THE FOLLOW-UP REPORT. WHEN ADDITIONAL INFO THAT IS PERTINENT TO THIS EVENT BECOMES AVAILABLE, I-FLOW WILL SUBMIT A FOLLOW-UP REPORT.

    Description of Event or Problem · 1

    PUMP INFUSED TOO QUICKLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ON-Q C-BLOC INFUSION PUMP MEB I-FLOW CORP. CB6007 812182

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other