BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ON-Q SILVERSOAKER

    MDR report key: 2043351 · Received February 25, 2011

    Report

    Report Number
    2026095-2011-00052
    Event Type
    Malfunction
    Date Received
    February 25, 2011
    Date of Event
    September 18, 2008
    Report Date
    September 19, 2008
    Manufacturer
    I-FLOW CORP.
    Product Code
    MEB
    PMA / PMN Number
    K063530
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DE, US
    Reporter Occupation
    PHARMACIST

    Narratives

    Additional Manufacturer Narrative · 1

    THE DIRECTIONS FOR USE (DFU) (1304267, REV. G): "CAUTION: DO NOT FILL LESS THAN MINIMUM OR EXCEED MAXIMUM FILL VOLUME." THE MAXIMUM FILL VOLUME FOR THIS PUMP IS 335ML. THE REPORTED FILL VOLUME WAS 340ML. IN ADDITION, THE DFU STATES: "FILLING THE PUMP LESS THAN NOMINAL, INCREASE FLOW RATE. FILLING THE PUMP GREATER THAN NOMINAL, DECREASE FLOW RATE." THE DFU ALSO INDICATES THAT WHEN FILLED TO NOMINAL VOLUME, FLOW RATE ACCURACY IS +/-15% OF THE LABELED FLOW RATE WHEN INFUSION IS STARTED 0-8 H AFTER FILL AND DELIVERING NORMAL SALINE AS THE DILUENT AT 88 DEGREES F (31 DEGREES C) AGAINST A BACK PRESSURE OF 40CM OF WATER. A REVIEW OF THE LOT HISTORY SHOWED NO OTHER COMPLAINTS FOR THIS LOT. A DEVICE HISTORY RECORD WAS CONDUCTED, AND ALL MFG OPERATIONS WERE FOUND TO BE WITHIN SPEC. I-FLOW RECEIVED ONE EMPTY AND USED PUMP FOR EVAL AND INVESTIGATION. THE PUMP WAS REFILLED WITH NORMAL SALINE SOLUTION TO THE REPORTED FILL VOLUME OF 340ML AND A FLOW RATE ACCURACY TEST WAS PERFORMED. THE PUMP WAS FOUND TO MEET SPEC. PRODUCT COMPLAINT IS NOT CONFIRMED FOR FAST FLOW.

    Description of Event or Problem · 1

    (DRUG/DILUENT: ROPIVACAINE 0.25%). THE PUMP WAS REPORTED TO FLOW FOR 48 HOURS AND FILLED AT 340ML AND FLOW AT 5ML/HR. THIS IS OVER THE MAXIMUM FILL VOLUME FOR THIS PART NUMBER. NO ADVERSE EVENT OCCURRED. PER DFU: NOMINAL FILL VOLUME: 270ML AND NOMINAL FLOW RATE: 5ML/HR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ON-Q SILVERSOAKER ELASTOMERIC PUMP MEB I-FLOW CORP. PM014-A 852804

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK