BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ON-Q SILVERSOAKER

    MDR report key: 2100753 · Received May 19, 2011

    Report

    Report Number
    2026095-2011-00140
    Event Type
    Injury
    Date Received
    May 19, 2011
    Date of Event
    April 6, 2011
    Report Date
    April 20, 2011
    Manufacturer
    I-FLOW CORP.
    Product Code
    MEB
    PMA / PMN Number
    K063530
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    METHOD: NO PRODUCT WAS RETURNED FOR EVALUATION AND INVESTIGATION. THE LOT NUMBER WAS NOT PROVIDED, THEREFORE THE DEVICE HISTORY RECORDS COULD NOT BE REVIEWED. RESULTS: WITHOUT THE ACTUAL PRODUCT, AN ANALYSIS CANNOT BE CONDUCTED. IF ADDITIONAL INFORMATION PERTINENT TO THIS COMPLAINT OR THE SAMPLE IS RECEIVED, A FOLLOW-UP REPORT WILL BE FILED.

    Description of Event or Problem · 1

    (DRUG/DILUENT: BUPIVACAINE 0.5%). (FILL VOLUME: 300ML & FLOW RATE: 4 ML/HR). (PROCEDURE: ROBOTIC LAP HYSTERECTOMY). (CATHPLACE: SUPRAPUBIC). PATIENT DEVELOPED JAUNDICE AND ELEVATED LIVER FUNCTION FOLLOWING THE USE OF AN ON-Q PUMP. SURGERY ON (B)(6) 2011. PATIENT HAD NORMAL LIVER FUNCTION TEST (LFT) PRIOR TO SURGERY. POST-OPERATIVELY, PATIENT REQUIRED A BLOOD TRANSFUSION. ABOUT 2-3 WEEKS AFTER SURGERY, PATIENT EXPERIENCED YELLOW SKIN AND ELEVATED LFT. ACUTE (B)(4) PANEL WAS NEGATIVE. PATIENT IS STABLE NOW. DATE OF EVENT: (B)(6) 2011.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ON-Q SILVERSOAKER ELASTOMERIC PUMP MEB I-FLOW CORP. PM025-A ANP*

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR Other