BEUDAMED
    FDA Adverse Event Other Summary report: N

    ON-Q C-BLOC

    MDR report key: 1010131 · Received March 7, 2008

    Report

    Report Number
    2026095-2008-00020
    Event Type
    Other
    Date Received
    March 7, 2008
    Date of Event
    January 1, 2008
    Report Date
    February 8, 2008
    Manufacturer
    I-FLOW CORP.
    Product Code
    MEB
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    EVAL SUMMARY: INITIAL REPORTER INDICATED THAT THE SAMPLE WAS NOT AVAILABLE FOR EVAL. THE INFO CONTAINED HEREIN IS BASED ON THE INFO PROVIDED BY THE INITIAL REPORTER. THE ACTUAL PART NUMBER AND LOT NUMBER WERE NOT PROVIDED. THE INITIAL REPORTER STATED THAT A PUMP HAD BEEN SET UP BY A PACU NURSE INCORRECTLY, LEAVING THE LARGE RED TAB IN PLACE ON THE BOLUS (PCA). THIS ALLOWED A LARGE AMOUNT OF MEDICATION TO BE DELIVERED TO A PT IN A SHORTER TIME THAN EXPECTED. NO INFO ON CONDITION OF PT HAS BEEN RECEIVED. THE DIRECTIONS FOR USE (DFU) CONTAIN A WARNING THAT STATES: "TO REDUCE POTENTIAL ADVERSE EFFECTS: 2. RED TAB MUST BE REMOVED BEFORE USE. 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." THE RED TAB IN THE BOLUS IS APPROX 1" WIDE, AND ALSO HAS A LARGE WHITE FLAG LABEL WITH RED WRITING THAT STATES "THIS SIDE UP FOR PRIMING. REMOVE RED TAB BEFORE USE." THE FACILITY HAS IMPLEMENTED NEW PROTOCOLS TO REDUCE THE RISK OF THIS OCCURRING IN THE FUTURE. IF ADD'L INFO THAT IS PERTINENT TO THIS EVENT BECOMES AVAILABLE, I-FLOW WILL SUBMIT A FOLLOW-UP REPORT.

    Description of Event or Problem · 1

    A PACU NURSE HOOKED UP A C-BLOC PUMP, BUT FORGOT TO REMOVE THE RED PLUG AFTER THE PRIME. PT RECEIVED 600 ML .2 ROPIVICAINE IN 15 HRS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ON-Q C-BLOC INFUSION PUMP MEB I-FLOW CORP. CB003 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Other