BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ON-Q PAINBUSTER: SILVERSOAKER 5IN: 400ML, 5ML/HR

    MDR report key: 3201765 · Received June 28, 2013

    Report

    Report Number
    2026095-2013-00118
    Event Type
    Injury
    Date Received
    June 28, 2013
    Date of Event
    June 1, 2013
    Report Date
    June 1, 2013
    Manufacturer
    I-FLOW, LLC
    Product Code
    MEB
    PMA / PMN Number
    K063530
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    METHOD: THE SAMPLE WILL NOT BE RETURNED. RESULTS: A REVIEW OF THE DEVICE HISTORY RECORD (DHR) WAS CONDUCTED FOR THE LOT NUMBER PROVIDED, AND THE DEVICE PASSED ALL MANUFACTURING SPECIFICATIONS PRIOR TO RELEASE. CONCLUSIONS: BASED ON THE INFO RECEIVED, THERE IS A POSSIBILITY THAT THE PT MAY HAVE RECEIVED A DAILY DOSAGE OF MEDICATION OVER 400MG. INFO FROM THIS INCIDENT WILL BE INCLUDED IN OUR PRODUCT COMPLAINT AND MDR TREND REPORTING SYSTEM. ADDITIONAL INVESTIGATION MAY ARISE FROM ONGOING ANALYSIS, TREND INFO, OR OTHER ANALYSIS AS APPROPRIATE.

    Description of Event or Problem · 1

    DRUG/DILUENT: 0.5% MARCAINE. FILL VOLUME: 400 ML. FLOW RATE: 5.0 ML/HR. PROCEDURE: LAPAROSCOPICALLY ASSISTED VAGINAL HYSTERECTOMY (LAVH). CATHPLACE: VAGINAL CUFF. THE PT UNDERWENT LAVH ON (B)(6) 2013. SHE HAD HISTORY OF SEIZURES BUT WAS IN REMISSION FOR 7 YEARS. ON (B)(6) 2013, HER HUSBAND CALLED I-FLOW'S CLINICAL SUPPORT LINE AND REPORTED THE PT FELT DIZZY, SIGNS OF HER PRE-SEIZURE ACTIVITIES. THEY WERE ADVISED TO CLAMP THE PUMP AND SEEK HELP AT AN ER. THE DEVICE WAS FILLED AND INFUSION BEGAN ON: (B)(6) 2013, INFUSION,AND END DATE: (B)(6) 2013. (NO TIME WAS SPECIFIED). (ADDITIONAL INFO RECEIVED (B)(6) 2013). THE PT REPORTED THAT THE ER PHYSICIAN TOLD HER THE SYMPTOMS WERE RELATED TO ANESTHESIA. THE ER DOCTOR SUGGESTED BLOOD WORK TO BE DRAWN BUT THE PT DECLINED. THE PT REPORTED SHE HAS BEEN DOING FINE. NO SEIZURE OCCURRED. THERE WAS NO REPORT TO THE DOCTOR'S OFFICE REGARDING THE PUMP ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    294920 ON-Q PAINBUSTER: SILVERSOAKER 5IN: 400ML, 5ML/HR ELASTOMERIC PUMP MEB I-FLOW, LLC PM026-A 0200794462

    Patients

    Seq Age Sex Outcome Treatment
    1 Other