BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ON-Q C-BLOC WITH SAF

    MDR report key: 2043245 · Received February 25, 2011

    Report

    Report Number
    2026095-2011-00056
    Event Type
    Malfunction
    Date Received
    February 25, 2011
    Date of Event
    November 18, 2008
    Report Date
    November 21, 2008
    Manufacturer
    I-FLOW CORP.
    Product Code
    MEB
    PMA / PMN Number
    K063530
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    A REVIEW OF THE DEVICE HISTORY RECORD WAS CONDUCTED, AND ALL MFG OPERATIONS WERE FOUND TO BE WITHIN SPECIFICATION. A REVIEW OF THE LOT HISTORY FOUND NO OTHER COMPLAINTS FOR THE LOT. I-FLOW RECEIVED ONE PARTIALLY FULL PUMP FOR EVAL AND INVESTIGATION. VISUAL EXAM REVEALED THAT THE PUMP WAS RECEIVED WITH THE PINCH CLAMP MISSING AND A KNOT IN THE TUBING. THE DIRECTIONS FOR USE (PN 1304265, REV. G), "CLAMP IS PROVIDED TO STOP THE INFUSION. DO NOT REMOVE OR BREAK CLAMP." THE KNOT WAS UNDONE, AND THE PUMP WAS REFILLED WITH NORMAL SALINE SOLUTION TO THE REPORTED FILL VOLUME OF 550ML. A FLOW RATE ACCURACY TEST WAS PERFORMED. THE FLOW RATE ACCURACY TESTING WAS WITHIN SPECIFICATION. PRODUCT COMPLAINT IS NOT CONFIRMED FOR FAST FLOW.

    Description of Event or Problem · 1

    (DRUG/DILUENT: ROPIVACAINE 0.5%). (PROCEDURE: SHOULDER ARTHROSCOPY). FAST FLOW. THE PUMP WAS FILLED TO 550 ML SET AT 8 ML/HR. AFTER 24 HRS POST OP, THERE WAS LESS THAN 200 MLS IN PUMP. PER DFU: NOMINAL FILL VOLUME: 400ML AND MAXIMUM FILL VOLUME: 550ML. SAF FLOW RATE: 2, 4, 6, 8, 10, 12, AND 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 882195

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK