BEUDAMED
    FDA Adverse Event Other Summary report: N

    ON-Q C-BLOC

    MDR report key: 1014117 · Received March 14, 2008

    Report

    Report Number
    2026095-2008-00022
    Event Type
    Other
    Date Received
    March 14, 2008
    Date of Event
    February 1, 2008
    Report Date
    February 14, 2008
    Manufacturer
    I-FLOW CORP.
    Product Code
    MEB
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION SUMMARY: THE SAMPLES WERE RECEIVED FOR EVALUATION AND INVESTIGATION. THE INFORMATION CONTAINED HEREIN IS BASED ON THE INFORMATION PROVIDED BY THE INITIAL REPORTER. THE REPORT STATED THAT TWO PUMPS HAD BEEN FILLED BY THE PHARMACY, BUT THE FILL VOLUME USED WAS ONLY 200ML AND 210ML RESPECTIVELY. THE NOMINAL FILL VOLUME FOR THESE PUMPS IS 400ML. THIS UNDERFILL OF THE PUMPS CAUSED THE PUMPS TO FLOW QUICKLY. THE DIRECTIONS FOR USE (DFU) CONTAIN CAUTIONS FOR UNDERFILLING THE PUMP. THE CAUTION STATES "DO NOT UNDERFILL. UNDERFILLING THE PUMP MAY SIGNIFICANTLY INCREASE THE FLOW RATE. FILLING THE PUMP LESS THAN NOMINAL RESULTS IN FASTER FLOW RATE." BECAUSE OF THE INFORMATION PROVIDED FOR THIS COMPLAINT, THE ACTUAL SAMPLES WERE NOT TESTED. IF ADDITIONAL INFORMATION THAT IS PERTINENT TO THIS EVENT BECOMES AVAILABLE, I-FLOW WILL SUBMIT A FOLLOW-UP REPORT.

    Description of Event or Problem · 1

    BOTH PUMPS EMPTIED TOO FAST. PUMPS WERE UNDERFILLED BY PHARMACY. PHARMACY ADDED 200CC AND 210CC OF NAROPIN TO THE PUMPS, BUT FORGOT TO DILUTE WITH THE NORMAL SALINE (NS).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ON-Q C-BLOC INFUSION PUMP MEB I-FLOW CORP. CB004 7B2792

    Patients

    Seq Age Sex Outcome Treatment
    1 Other