BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ON-Q SILVERSOAKER

    MDR report key: 957308 · Received November 29, 2007

    Report

    Report Number
    2026095-2007-00061
    Event Type
    Malfunction
    Date Received
    November 29, 2007
    Report Date
    November 15, 2007
    Manufacturer
    I-FLOW CORP.
    Product Code
    MEB
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION SUMMARY: THE DEVICE INVOLVED IN THIS INCIDENT WAS NOT AVAILABLE FOR EVALUATION. WITHOUT THE ACTUAL PRODUCT, A COMPLETE ANALYSIS CANNOT BE CONDUCTED. THEREFORE, THE INFO CONTAINED HEREIN WAS BASED ON THE INFO PROVIDED BY THE INITIAL REPORTER. A REVIEW OF THE DEVICE HISTORY RECORD WAS PERFORMED, AND ALL MANUFACTURING OPERATIONS WERE FOUND TO BE WITHIN THE LIMITS. IN ADDITION, RETAIN SAMPLES FROM LOT 772161 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 THE NOMINAL LIMITS. IN ADDITION, ONE RETAIN PUMP WAS FILLED WITH NORMAL SALINE SOLUTION TO THE REPORTED FILL VOLUME OF 281 ML AND A FLOW RATE ACCURACY TEST WAS PERFORMED. THE FLOW ACCURACY TEST RESULTS WERE FOUND TO BE WITHIN THE LIMITS. BASED ON THE TEST RESULT, WE WERE UNABLE TO CONFIRM THE FAST FLOW ON THE RETAINED DEVICES TESTED. IF 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 IN 24 HRS INSTEAD OF 76 HRS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ON-Q SILVERSOAKER INFUSION PUMP MEB I-FLOW CORP. PM024-A 772161

    Patients

    Seq Age Sex Outcome Treatment
    1 YR Other