BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ON-QPAINBUSTER: SILVERSOAKER5IN:400ML, 2+2ML/HR

    MDR report key: 4110727 · Received September 16, 2014

    Report

    Report Number
    2026095-2014-00177
    Event Type
    Malfunction
    Date Received
    September 16, 2014
    Date of Event
    August 10, 2014
    Report Date
    August 20, 2014
    Manufacturer
    I-FLOW, LLC.
    Product Code
    MEB
    PMA / PMN Number
    K063530
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    METHOD: THE DEVICE WAS REPORTED TO BE AVAILABLE FOR ANALYSIS AND PENDING RETURN AT THIS TIME. A REVIEW OF THE DEVICE HISTORY RECORD (DHR) WAS CONDUCTED FOR THE LOT NUMBER REPORTED. RESULTS: AT THIS TIME THE INVESTIGATION IS STILL IN PROGRESS. ONCE THE DEVICE IS RECEIVED, TESTING WILL BE PERFORMED AND RESULTS WILL BE PROVIDED ONCE COMPLETED. PER THE DHR THERE WERE NO RE-WORKS, SPECIAL CONDITIONS, OR RELATED NON-CONFORMANCE REPORTS (NCRS) FOR THIS LOT. THE LOT MET THE PROCESS SPECIFICATIONS PRIOR TO RELEASE. CONCLUSIONS: ONCE THE INVESTIGATION AND DEVICE ANALYSIS ARE COMPLETED, A FOLLOW-UP REPORT WILL BE SUBMITTED. INFORMATION FROM THIS INCIDENT WILL BE INCLUDED IN OUR PRODUCT COMPLAINT AND MDR TREND REPORTING SYSTEM. ADDITIONAL INVESTIGATION MAY ARISE FROM ONGOING ANALYSIS, TREND INFORMATION, OR OTHER ANALYSIS AS APPROPRIATE.

    Description of Event or Problem · 1

    FILL VOLUME: 335 ML. FLOW RATE: 4 ML. PROCEDURE: BILATERAL MASTECTOMIES WITH PLACEMENT OF TISSUE EXPANDERS. CATHPLACE: UPPER, MEDIAL ASPECT OF MASTECTOMY FIELD, BETWEEN SKIN AND MUSCLE. IT WAS REPORTED BY A PATIENT TO HER PHYSICIAN THAT AN ON-Q PUMP DID NOT SEEM TO BE WORKING FOR THE FIRST TWO DAYS, AS THE BULB WAS NOT DECREASING IN SIZE AND THEN IT EMPTIED SUDDENLY ON THE THIRD DAY. IT WAS REPORTED THAT THE PATIENT FELT HER ENTIRE CHEST WENT NUMB. THERE WAS NO MEDICAL INTERVENTION REQUIRED FOR THE REPORTED INCIDENT. THE PATIENT'S CURRENT CONDITION IS UNREMARKABLE. THIS PUMP WAS FILLED ON (B)(6) 2014 AROUND 12:26 PM AND THE INFUSION WAS STARTED ABOUT THE SAME TIME. THE PATIENT NOTICED THE INCIDENT IN THE MORNING OF (B)(6) 2014.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    572033 ON-QPAINBUSTER: SILVERSOAKER5IN:400ML, 2+2ML/HR ELASTOMERIC PUMP MEB I-FLOW, LLC. PM025-A 0201326829

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR TEGADERM| TISSUE EXPANDERS| DRUG: 0.5% MARCAINE