BEUDAMED
    FDA Adverse Event Other Summary report: N

    ON-Q C-BLOC

    MDR report key: 1837333 · Received September 14, 2010

    Report

    Report Number
    2026095-2010-00208
    Event Type
    Other
    Date Received
    September 14, 2010
    Date of Event
    September 17, 2006
    Report Date
    September 8, 2010
    Manufacturer
    I-FLOW CORP.
    Product Code
    MEB
    PMA / PMN Number
    K063530
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    RECEIVED ONE EMPTY AND USED PUMP FOR EVALUATION AND INVESTIGATION. VISUAL INSPECTION FOUND THE SELECT-A-FLOW (SAF) WAS SET AT 6 ML/HOUR. EXAMINATION OF THE DEVICE INDICATED THAT THE RED TAB IN THE BOLUS WAS NOT REMOVED PRIOR TO USE. THE DIRECTIONS FOR USE (DFU) (PN 1306085, REV. A) STATES: WARNING: IF RED TAB IS NOT REMOVED BEFORE USE OR BREAKS WHILE REMOVING, BOLUS BUTTON WILL NOT WORK AND FLOW RATE MAY INCREASE SIGNIFICANTLY ABOVE THE TOTAL FLOW RATE. TOTAL FLOW RATE REFERS TO BOLUS + BASAL. THE BEST EVIDENCE INDICATES THAT THE PCA PRIMING PROCESS WAS NOT FOLLOWED PER THE DFU. NO DISCREPANCIES WERE NOTED WITH THE RED TAB.

    Description of Event or Problem · 1

    PUMP INFUSED IN 24 INSTEAD OF 40 HOURS. FILL VOLUME 400 ML, SAF AT 10 ML/HR. WHEN PUMP WAS RETURNED, RED TAB WAS STILL IN BOLUS DEVICE. NO PATIENT PROBLEMS OCCURRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ON-Q C-BLOC ELASTOMERIC PUMP MEB I-FLOW CORP. CB006 972530

    Patients

    Seq Age Sex Outcome Treatment
    1 Other