BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ON-Q PAINBUSTER

    MDR report key: 2043329 · Received February 25, 2011

    Report

    Report Number
    2026095-2011-00053
    Event Type
    Malfunction
    Date Received
    February 25, 2011
    Date of Event
    October 20, 2008
    Report Date
    October 24, 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
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HISTORY RECORD WAS REVIEWED, AND ALL MFG OPERATIONS WERE FOUND TO BE WITHIN SPECIFICATION. A REVIEW OF THE LOT HISTORY REVEALED IT WAS THE ONLY COMPLAINT FOR THIS LOT. I-FLOW RECEIVED ONE EMPTY AND USED PUMP FOR EVAL AND INVESTIGATION. THE PUMP WAS REFILLED WITH NORMAL SALINE SOLUTION TO THE NORMAL FILL VOLUME OF 400ML AND INFUSION WAS VERIFIED. A FLOW RATE ACCURACY TEST WAS PERFORMED AND ALL THREE CATHETERS INFUSED WITHIN SPECIFICATION. PRODUCT COMPLAINT IS NOT CONFIRMED FOR FAST FLOW.

    Description of Event or Problem · 1

    (DRUG/DILUENT: ROPIVACAINE 0.375%). (PROCEDURE: RIB FRACTURE). PUMP INFUSION WITHIN 48 HOURS. FILL VOLUME 400ML AND FLOW RATE 2ML/HR. NO ADVERSE EVENT OCCURRED. DATE OF EVENT: (B)(6) 2008. PER DFU: LABELED FILL VOLUME: 400ML AND LABELED FLOW RATE: 6ML/HR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ON-Q PAINBUSTER ELASTOMERIC PUMP MEB I-FLOW CORP. P400X6T 852823

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK