BEUDAMED
    FDA Adverse Event Other Summary report: N

    ON-Q PAINBUSTER SOAKER

    MDR report key: 598128 · Received April 29, 2005

    Report

    Report Number
    2026095-2005-00024
    Event Type
    Other
    Date Received
    April 29, 2005
    Date of Event
    March 31, 2005
    Report Date
    April 25, 2005
    Manufacturer
    I-FLOW CORP.
    Product Code
    MEB
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    SIGNS/SYMPTOMS OF LOCAL ANESTHETIC TOXICITY REPORTED. HOTLINE CALL FROM PT APPROXIMATELY 8 HOURS POST OP. PT COMPLAINED OF METALLIC TASTE IN MOUTH AND NAUSEA FOR 3 HOURS. PUMP INFUSING AT 5 ML/HR WITH O.5% BUPIVACAINE. PT WOULD HAVE RECEIVED APPROXIMATELY 200MG FROM THE ON-Q. IT IS UNKNOWN WHETHER PT RECEIVED ADDITIONAL LOCAL ANESTHETIC AS A PRE-OP/POST-OP BOLUS. TUBING CLAMP WAS NOT ON TUBING, SO PT COULD NOT CLOSE CLAMP TO STOP INFUSION. A CALL WAS IMMEDIATELY PLACED TO PT'S DOCTOR. THE DOCTOR ON-CALL CALLED THE PT AND ADVISED PT TO REMOVE THE PUMP. PT'S SPOUSE WAS WALKED THROUGH THE REMOVAL OF THE CATHETER BY THE HOTLINE, R.N. CATHETER WAS REMOVED WITHOUT DIFFICULTY. DOCTOR AND O.R. STAFF WERE ACCUSTOMED TO USING 0.5% WITH A 2 ML/HR PUMP. USING A 5 ML/HR PUMP WITH 0.5% EXCEEDED THE MAXIMUM RECOMMENDED DOSE. MAX DOSE = 400MG/DAY. PT WOULD HAVE RECEIVED 600MG/DAY WITH THIS INFUSION. THE DOCTOR AND STAFF ARE AWARE AND WILL USE LOWER CONCENTRATON IN THE FUTURE. PT ALSO MAY HAVE HAD ADDITIONAL BOLUS OF LOCAL ANESTHETIC DURING SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ON-Q PAINBUSTER SOAKER INFUSION PUMP MEB I-FLOW CORP. PM024 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other