BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ON-Q, 400ML, 1-7ML/HR + 5ML/60MINS, PUMP

    MDR report key: 2191925 · Received July 22, 2011

    Report

    Report Number
    2026095-2011-00200
    Event Type
    Malfunction
    Date Received
    July 22, 2011
    Date of Event
    June 30, 2011
    Report Date
    June 30, 2011
    Manufacturer
    I-FLOW CORP.
    Product Code
    MEB
    PMA / PMN Number
    K063530
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    METHOD: SAMPLE HAS NOT YET BEEN RECEIVED, BUT WAS REPORTED TO BE AVAILABLE. 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: WITHOUT THE ACTUAL PRODUCT OR A LOT NUMBER, A COMPLETE ANALYSIS CANNOT BE CONDUCTED. CONCLUSIONS: THE SAMPLE WILL BE EVALUATED WHEN RECEIVED AND A FOLLOW-UP REPORT WILL BE FILED.

    Description of Event or Problem · 1

    DRUG/DILUENT: ROPIVACAINE. FILL VOLUME: 550ML AND FLOW RATE: 6 OR 7ML/HR. PROCEDURE: SHOULDER. CATHPLACE: SHOULDER. BOLUS (LVPCA) WOULD NOT DELIVER THE MEDICATION WHEN BUTTON WAS PUSHED, THE BUTTON STAYED DOWN. THE FILL INDICATOR NEVER WENT DOWN. PT'S NEIGHBOR (A NURSE) USED SCREWDRIVER TO PRY BUTTON BACK UP. DID NOT POP BACK UP EVEN WHEN DISCONNECTED FROM CATHETER. WORKED FINE INITIALLY (APPROX FIRST 24 HOURS). NO ADVERSE EVENT OCCURRED. DATE OF EVENT: (B)(6) 2011.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ON-Q, 400ML, 1-7ML/HR + 5ML/60MINS, PUMP ELASTOMERIC PUMP MEB I-FLOW CORP. P400X1-7+5/60 132463

    Patients

    Seq Age Sex Outcome Treatment
    1