BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ON-Q SS

    MDR report key: 2190147 · Received March 10, 2011

    Report

    Report Number
    2026095-2011-00078
    Event Type
    Malfunction
    Date Received
    March 10, 2011
    Date of Event
    February 18, 2011
    Report Date
    February 18, 2011
    Manufacturer
    I-FLOW CORP.
    Product Code
    MEB
    PMA / PMN Number
    K063530
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    A REVIEW OF THE DEVICE HISTORY RECORDS (DHR) WAS CONDUCTED FOR THE LOT NUMBER AND INCIDENT REPORTED. THE DEVICE PASSED ALL MFG SPECS PRIOR TO RELEASE. RESULTS: SAMPLE HAS NOT YET BEEN RECEIVED, BUT WAS REPORTED TO BE AVAILABLE. CONCLUSION: THE SAMPLE WILL BE EVALUATED WHEN RECEIVED AND A F/U REPORT WILL BE FILED.

    Description of Event or Problem · 1

    DRUG/DILUENT: MARCAINE 0.25%. FILL VOLUME: 120ML AND FLOW RATE: 2ML/HR. PROCEDURE: HERNIA REPAIR. CATHPLACE: GROIN. FAST FLOW. PT WAS TOLD PUMP SHOULD LAST FROM WEDNESDAY TO SATURDAY, BUT ACCORDING TO PT, PUMP WAS EMPTY BY THURSDAY EVENING. PT SAID HE REMOVED THE CATHETER ON FRIDAY, BUT KNEW THE PUMP WAS EMPTY ON THURSDAY BECAUSE IT WAS WRINKLED AND SHRUNKEN. REPORTED INFUSION STARTED (B)(6) 2011 AT 10:05 AM AND ENDED THE EVENING OF(B)(6) 2011. SALES REP SPOKE TO SURGEON WHO FELT COMPLAINT WAS PT ISSUE, NOT PUMP ISSUE. DATE OF EVENT: (B)(6), 2011. PER DFU: LABELED FLOW RATE: 2ML/HR. LABELED FILL VOLUME: 100ML. MAXIMUM FILL VOLUME: 125ML. THE INFUSION RATE IS 50 HOURS WHEN FILLED TO THE LABELED VOLUME AND FLOW RATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ON-Q SS ELASTOMERIC PUMP MEB I-FLOW CORP. PM012-A 0A2604

    Patients

    Seq Age Sex Outcome Treatment
    1