BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ON-Q PAINBUSTER

    MDR report key: 2003848 · Received February 24, 2011

    Report

    Report Number
    2026095-2011-00062
    Event Type
    Injury
    Date Received
    February 24, 2011
    Date of Event
    January 28, 2011
    Report Date
    January 28, 2011
    Manufacturer
    I-FLOW CORP.
    Product Code
    MEB
    PMA / PMN Number
    K063530
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    METHOD: NO PRODUCT WAS RETURNED FOR EVALUATION AND INVESTIGATION. A DEVICE HISTORY RECORD WAS CONDUCTED, AND ALL MANUFACTURING OPERATIONS WERE FOUND TO BE WITHIN SPECIFICATION. RESULTS: RISK MANAGEMENT WILL NOT RELEASE PUMP FOR EVALUATION. WILL BE ADVISED BY FACILITY IF SAMPLE BECOMES AVAILABLE. IF ADDITIONAL INFORMATION PERTINENT TO THIS COMPLAINT OR THE SAMPLE IS RECEIVED, I-FLOW WILL SUBMIT A FOLLOW-UP REPORT.

    Description of Event or Problem · 1

    (DRUG/DILUENT: MARCAINE 0.5%). (PROCEDURE: C-SECTION). (CATHPLACE: ONE ON THE MUSCLE, ONE ON THE FASCIA). PATIENT DEVELOPED TACHYCARDIA. PATIENT WAS SET UP ON PUMP AFTER C-SECTION. A BOLUS OF 5ML MARCAINE 0.5% WAS GIVEN WHILE STILL IN OPERATING ROOM. PATIENT TAKEN TO RECOVERY AT 1415. SOMETIME THEREAFTER, THE CLAMP WAS OPENED. AROUND 1528 PATIENT DEVELOPED TACHYCARDIA. ADENOSINE WAS ADMINISTERED AND PUMP WAS DISCONTINUED. PATIENT ADMITTED TO TELEMETRY. FOLLOW-UP ON DAY 2 AND 3 FOUND THE PATIENT DOING WELL AND TRANSFERRED BACK TO L&D FLOOR. AS OF (B)(6) 2011, RISK MANAGEMENT WILL NOT RELEASE PUMP FOR EVALUATION. WILL BE ADVISED BY FACILITY IF SAMPLE BECOMES AVAILABLE. DATE OF EVENT: (B)(6) 2011.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ON-Q PAINBUSTER ELASTOMERIC PUMP MEB I-FLOW CORP. P270X4D 0B2691

    Patients

    Seq Age Sex Outcome Treatment
    1 40 YR Other