BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ON-Q PAINBUSTER INTL

    MDR report key: 2142120 · Received May 26, 2011

    Report

    Report Number
    2026095-2011-00157
    Event Type
    Malfunction
    Date Received
    May 26, 2011
    Date of Event
    October 14, 2010
    Report Date
    October 19, 2010
    Manufacturer
    I-FLOW CORP.
    Product Code
    MEB
    PMA / PMN Number
    K063530
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SW
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    A REVIEW OF THE DEVICE HISTORY RECORDS (DHR) WAS CONDUCTED FOR THE LOT NUMBER AND INCIDENT REPORTED. THE DEVICE PASSED ALL MFG SPECIFICATIONS PRIOR TO RELEASE. THE DIRECTIONS FOR USE (1304458, REV. C) FILLED TO THE NOMINAL VOLUME, FLOW RATE ACCURACY IS +/- 15% OF THE LABELED INFUSION RATE WHEN INFUSION IS STARTED 0-8 HRS AFTER FILL AND DELIVERING NORMAL SALINE SOLUTION AS THE DILUENT AT 88 DEGREE F (31 DEGREE C) AGAINST A BACK PRESSURE OF 40 CM OF WATER. THE TYPICAL FLOW CURVE FOR ELASTOMERIC PUMPS IS PROVIDED IN THE DIRECTIONS FOR USE (1304457, REV. E), INCLUDED WITH THE PUMP. THE DIFFERENCES IN MEASURING TECHNIQUE, TIME, AND TEMPERATURE MAY ACCOUNT FOR THE SLIGHTLY ABOVE SPECIFICATION INFUSION EXPERIENCED. REC'D ONE EMPTY, USED PUMP FOR EVAL AND INVESTIGATION. NO VISUAL DISCREPANCIES WERE NOTED. THE PUMP WAS REFILLED WITH NORMAL SALINE SOLUTION TO THE NOMINAL FILL VOLUME OF 270ML AND A FLOW RATE ACCURACY TEST WAS PERFORMED. THE PUMP INFUSED WITHIN SPECIFICATION. THE COMPLAINT OF A FAST FLOW WAS NOT CONFIRMED.

    Description of Event or Problem · 1

    DRUG/DILUENT: ROPIVACAINE 3.7MG/ML. FILL VOLUME: 270ML. FLOW RATE: 2ML/HR. PROCEDURE: UNK. CATHPLACE: UNK. PUMPS ARE INFUSING TOO FAST. ONE PT HAD 2 PUMPS. LEFT PUMP 21.5ML/52.75 HOURS; RIGHT PUMP 12.5ML/52.75 HOURS. TOTAL 34ML/52.75 HOURS. NO ADVERSE EVENT OCCURRED. DATE OF EVENT: (B)(6) 2010. PER DFU: NOMINAL FLOW RATE: 2ML/HR. NOMINAL FILL VOLUME: 270ML. MAXIMUM FILL VOLUME: 335ML. THE INFUSION DELIVERY TIME IS 135 HOURS WHEN FILLED TO NOMINAL VOLUME AND FLOW RATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ON-Q PAINBUSTER INTL ELASTOMERIC PUMP MEB I-FLOW CORP. PS12503 032658

    Patients

    Seq Age Sex Outcome Treatment
    1 4 YR