BEUDAMED
    FDA Adverse Event Other Summary report: N

    ON-Q SILVERSOAKER

    MDR report key: 1149426 · Received September 5, 2008

    Report

    Report Number
    2026095-2008-00135
    Event Type
    Other
    Date Received
    September 5, 2008
    Date of Event
    August 13, 2008
    Report Date
    August 13, 2008
    Manufacturer
    I-FLOW CORP.
    Product Code
    MEB
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    THE INFORMATION CONTAINED HEREIN IS BASED ON THE INFORMATION PROVIDED BY THE INITIAL REPORTER. THE REPORT STATED THAT THE PATIENT WAS SUSPECTED OF HAVING MARCAINE TOXICITY. THE INFORMATION PROVIDED INDICATED THAT THE PATIENT HAD TWO PUMPS RUNNING SIMULTANEOUSLY, RECEIVING A TOTAL OF 9ML OF 0.5% MARCAINE, WHICH IS 1080 MG/DAY. THE DRUG MANUFACTURER DRUG INSERT SUGGESTS LIMITING 24 HOUR DOSAGE TO 400MG. THE SYMPTOMS OF THE PATIENT COULD BE RELATED TO THE HIGH DOSAGE DELIVERED. THE PUMP WAS ALSO ALTERED BY THE PHYSICIAN WHEN THE PINCH CLAMPS WERE BROKEN OFF. THE DIRECTIONS FOR USE (DFU) CONTAIN A WARNING THAT STATES: "CLAMP IS PROVIDED TO STOP THE INFUSION. DO NOT REMOVE OR BREAK CLAMP. DO NOT USE CLAMP AS AN INTERMITTENT DELIVERY DEVICE." THE PUMPS ARE BEING RETURNED FOR EVALUATION, BUT HAVE NOT YET BEEN RECEIVED. COMPLAINT IS UNDER INVESTIGATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT WAS SUSPECTED OF HAVING MARCAINE TOXICITY. THE PATIENT HAD TWO PUMPS RUNNING SIMULTANEOUSLY, (ONE AT 4ML/HR AND ONE AT 5ML/HR) FOLLOWING BI-LATERAL MASTECTOMY SURGERY. THE PHYSICIAN BROKE THE CLAMPS OFF OF THE TUBING TO ENSURE THEY WOULD NOT ACCIDENTALLY GET CLOSED. THESE PROVIDED A TOTAL OF 9 ML/HR OF 0.5% MARCAINE. THE PATIENT WOKE UP COMBATIVE AND CONFUSED. PATIENT WENT TO ER WHERE THE PUMPS WERE DISCONTINUED. BOTH PUMPS STILL HAD MEDICATION INSIDE. PUMP MODEL NUMBERS IDENTIFIED WERE: PM028A, LOT NO. 852766 AND PM014A, LOT NO. 7B2798.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ON-Q SILVERSOAKER INFUSION PUMP MEB I-FLOW CORP. PM028A 852756

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other