BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ON-Q C-BLOC: 400ML, 2-14ML/HR SELECT-A-FLOW

    MDR report key: 2738834 · Received September 7, 2012

    Report

    Report Number
    2026095-2012-00226
    Event Type
    Injury
    Date Received
    September 7, 2012
    Date of Event
    August 11, 2012
    Report Date
    August 11, 2012
    Manufacturer
    I-FLOW, LLC
    Product Code
    MEB
    PMA / PMN Number
    K063530
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    METHOD: THE PRODUCT WILL NOT BE RETURNED FOR EVALUATION AND INVESTIGATION. THE PUMP IS BEING MAINTAINED AND SEQUESTERED AT THE MEDICAL FACILITY. RESULTS: WITHOUT THE ACTUAL PRODUCT, AN ANALYSIS CANNOT BE CONDUCTED. CONCLUSION: IF ADDITIONAL INFORMATION PERTINENT TO THIS EVENT BECOMES AVAILABLE, OR A SAMPLE IS RECEIVED I-FLOW WILL REOPEN THE CASE REPORT.

    Description of Event or Problem · 1

    DRUG/DILUENT: 0.5% BUPIVACAINE. FILL VOLUME: 400 ML. FLOW RATE: 14.0 ML/HR. PROCEDURE: VENTRAL HERNIA / ABDOMINAL LIPODYSTROPHY. CATHPLACE: THREADED THROUGH THE LOWER ABDOMINAL TRANSVERSE INCISION IN THE SUPRAPUBIC AREA ENDING ON THE LEFT AND RIGHT ENDS. (PLEASE REFER TO: 2026095-2012-00223/12-00854 A) IT WAS REPORTED THAT 2 PUMPS FILLED WITH 400 ML EACH WERE NOTED TO BE ALMOST EMPTY AT 9 AM ON THE DAY AFTER THE SURGERY. THE PUMP ON THE LEFT SIDE OF THE PATIENT WAS SMALLER THAN THE PUMP ON THE RIGHT SIDE. PATIENT HAD SEIZURE ACTIVITIES AT 4AM AND 9AM ON (B)(6) 2012. THE PATIENT WAS TRANSFERRED TO ICU FOR TREATMENT. IT WAS LATER REPORTED THAT THE PATIENT WAS DISCHARGED FROM THE HOSPITAL. DATE OF SURGERY: (B)(6) 2012.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ON-Q C-BLOC: 400ML, 2-14ML/HR SELECT-A-FLOW ELASTOMERIC PUMP MEB I-FLOW, LLC CB004 152797

    Patients

    Seq Age Sex Outcome Treatment
    1 32 YR Other| R