BEUDAMED
    FDA Adverse Event Other Summary report: N

    ON-Q PUMP: 400 ML X 5 ML/HR

    MDR report key: 3216987 · Received July 3, 2013

    Report

    Report Number
    2026095-2013-00119
    Event Type
    Other
    Date Received
    July 3, 2013
    Date of Event
    June 5, 2013
    Report Date
    June 5, 2013
    Manufacturer
    I-FLOW LLC
    Product Code
    MEB
    PMA / PMN Number
    K063530
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    METHOD: THE DEVICE WILL NOT BE RETURNED TO I-FLOW AS A MALFUNCTION WAS NOT REPORTED, AND AN ADVERSE EVENT DID NOT OCCUR. CONCLUSIONS: AT THIS TIME, THIS COMPLAINT IS BEING FURTHER INVESTIGATED AND A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN I-FLOW HAS COMPLETED ITS INVESTIGATION. 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: UNKNOWN, FILL VOLUME: UNKNOWN, FLOW RATE: 5 ML/HR, PROCEDURE: UNKNOWN, CATHPLACE: UNKNOWN. AN I-FLOW SALES REPRESENTATIVE WAS AT A HOSPITAL TO SUPPORT A SURGERY. AN ON-Q PUMP WAS USED, AND IT WAS CONNECTED TO THE PATIENT IN THE PACU UNIT. WHEN THE SALES REPRESENTATIVE WENT TO CHECK IN WITH THE NURSE TO VERIFY EVERYTHING WAS CONNECTED CORRECTLY, IT WAS NOTICED THAT THE PUMP WAS CONNECTED TO THE PATIENT'S IV LINE. THERE WERE NO ADVERSE EVENT OR EFFECTS CAUSED TO THE PATIENT. THE INCIDENT WAS DOCUMENTED AND REPORTED WITHIN THE HOSPITAL AS WELL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    303511 ON-Q PUMP: 400 ML X 5 ML/HR ELASTOMERIC PUMP MEB I-FLOW LLC P400X5 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1