BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ON-Q C-BLOC WITH SAF

    MDR report key: 2043358 · Received February 25, 2011

    Report

    Report Number
    2026095-2011-00036
    Event Type
    Malfunction
    Date Received
    February 25, 2011
    Date of Event
    April 2, 2008
    Report Date
    April 4, 2008
    Manufacturer
    I-FLOW CORP.
    Product Code
    MEB
    PMA / PMN Number
    K063530
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DIRECTIONS FOR USE (DFU) CONTAINS A CAUTION FOR UNDERFILLING THE PUMP: "CAUTIONS: DO NOT UNDERFILL. UNDERFILLING THE PUMP MAY SIGNIFICANTLY INCREASE THE FLOW RATE." THE DEVICE HISTORY RECORD WAS CONDUCTED, AND ALL MFG OPERATIONS WERE FOUND TO BE WITHIN SPEC. I-FLOW RECEIVED 2 PARTIALLY FULL PUMPS FOR EVAL AND INVESTIGATION. THE PUMPS WERE REFILLED WITH NORMAL SALINE SOLUTION TO THE NOMINAL FILL VOLUME OF 400ML AND A FLOW ACCURACY TEST WAS PERFORMED. BOTH PUMPS FLOWED WITHIN SPEC. IN ADDITION, RETAIN SAMPLES FROM LOT 7A2742 WERE TESTED. THE PUMPS WERE FILLED WITH NORMAL SALINE SOLUTION TO THE NOMINAL FILL VOLUME OF 400ML AND A FLOW RATE ACCURACY TEST WAS PERFORMED USING 10ML/HR. THE FLOW RATE ACCURACY TEST RESULTS WERE FOUND TO BE WITHIN SPEC. PRODUCT COMPLAINT IS NOT CONFIRMED.

    Description of Event or Problem · 1

    (DRUG/DILUENT: ROPIVACAINE 0.2%). PUMP WAS IN USE 38-40 HOURS WHEN CALL RECEIVED ABOUT EMPTY PUMP. SHOULD HAVE RUN 50 HOURS. FILL VOLUME WAS TO BE 360ML AND FLOW RATE WAS TO BE 8ML/HR. PER DFU: NOMINAL FILL VOLUME: 400ML AND NOMINAL FLOW RATE: 2-14ML/HR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ON-Q C-BLOC WITH SAF ELASTOMERIC PUMP MEB I-FLOW CORP. CB004 7A2742

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK