BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ON-Q PAINBUSTER: SOAKER 5IN: 270ML, 5ML/HR

    MDR report key: 3823257 · Received February 19, 2014

    Report

    Report Number
    2026095-2014-00019
    Event Type
    Malfunction
    Date Received
    February 19, 2014
    Date of Event
    December 5, 2013
    Report Date
    January 22, 2014
    Manufacturer
    I-FLOW CORP.
    Product Code
    MEB
    PMA / PMN Number
    K063530
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    METHOD: AT THIS TIME I-FLOW IS PENDING THE RETURN OF THE DEVICE. ONCE RECEIVED AN INVESTIGATION AND EVALUATION WILL BE PERFORMED ON THE SAMPLE RETURNED. A REVIEW OF THE DEVICE HISTORY RECORD (DHR) WAS CONDUCTED FOR THE LOT NUMBER PROVIDED. RESULTS: RESULTS OF THE EVALUATION ARE IN PROGRESS. PER THE DHR THE LOT MEET MANUFACTURING SPECIFICATIONS AT RELEASE. CONCLUSIONS: A CONCLUSION IS NOT YET AVAILABLE AS THE SAMPLE IS PENDING INVESTIGATION AND EVALUATION ONCE RECEIVED. A FOLLOW-UP REPORT WILL BE FILED WHEN THE INVESTIGATION HAS BEEN COMPLETED. 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

    DRUG/DILUENT: 0.2% ROPIVACAINE. FILL VOLUME: 270ML. FLOW RATE: 5ML/HR. PROCEDURE: POPLITEAL BLOCK. CATHPLACE: UNKNOWN. AN INCIDENT OF FAST FLOW WAS REPORTED. INCIDENT OF FAST FLOW WAS REPORTED. INCIDENT AS REPORTED BY THE DISTRIBUTION: DEFECT CODE- "EMPTY TOO FAST- 24 INSTEAD OF 40, FUNCTION TOO HIGH" INCIDENT AS REPORTED BY THE CUSTOMER: "THE ELASTOMERIC PUMP WAS FILLED WITH 200ML NACI AND ROPIVACAINE 2% (200ML INSTEAD OF 270ML). EVEN IF ONE TAKES ACCOUNT OF THE FACT THAT ONLY 200ML IN 270ML CAUSES MORE RAPID INFUSION, IT IS UNACCEPTABLE FOR THE PUMP TO HAVE EMPTIED IN JUST 24 HOURS RATHER THAN 40 HOURS. APPARENTLY THE CAPILLARY WAS IN PERMANENT CONTACT WITH THE SKIN. PLEASE HAVE THE PUMP ANALYSED AND CHECKED FOR DEFECTS. A NUMBER OF INCIDENTS LIKE THIS HAVE BEEN REPORTED IN RECENT WEEKS." NO ADVERSE EVENTS OR MEDICAL INTERVENTION REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    104664 ON-Q PAINBUSTER: SOAKER 5IN: 270ML, 5ML/HR ELASTROMERIC PUMP MEB I-FLOW CORP. PS12504 0200704363

    Patients

    Seq Age Sex Outcome Treatment
    1