BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ON-Q PUMP 270ML, 5ML/HR

    MDR report key: 4708421 · Received April 20, 2015

    Report

    Report Number
    2026095-2015-00131
    Event Type
    Malfunction
    Date Received
    April 20, 2015
    Report Date
    March 25, 2015
    Manufacturer
    HALYARD - IRVINE
    Product Code
    MEB
    PMA / PMN Number
    PK063530
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). METHOD CODE: ACTUAL DEVICE NOT EVALUATED. METHOD: THE DEVICE WAS REPORTED AS NOT AVAILABLE FOR RETURN AND ANALYSIS. THE REPORTER WAS UNABLE TO PROVIDE A LOT NUMBER; THUS, THE DEVICE HISTORY RECORD (DHR) REVIEW CANNOT BE CONDUCTED. RESULTS: AS THE DEVICE AND LOT NUMBER WERE UNAVAILABLE FOR ANALYSIS, NO DEVICE TESTING METHODS WERE PERFORMED. FOR THIS REASON RESULTS CANNOT BE OBTAINED. PER THE INSTRUCTIONS FOR USE (IFU) THERE ARE SEVERAL FACTORS THAT MAY AFFECT THE FLOW RATE INCLUDING FILL VOLUME, TEMPERATURE, VISCOSITY OF THE DRUG SOLUTION, PUMP POSITION, STORAGE TIME AND EXTERNAL PRESSURE. CONCLUSIONS: THE DEVICE WAS NOT RETURNED TO HALYARD FOR EVALUATION, THEREFORE WE ARE UNABLE TO DETERMINE THE CAUSE FOR THE REPORTED EVENT. NO PATIENT INJURY WAS REPORTED. LIMITED INFORMATION WAS PROVIDED BY THE REPORTER. MULTIPLE ATTEMPTS WERE MADE TO OBTAIN ADDITIONAL INFORMATION WITHOUT SUCCESS. INFORMATION FROM THIS INCIDENT HAS BEEN INCLUDED IN OUR PRODUCT COMPLAINT AND MDR TREND REPORTING SYSTEMS. TREND INFORMATION IS USED TO IDENTIFY THE NEED FOR ADDITIONAL INVESTIGATIONS.

    Description of Event or Problem · 1

    PLEASE REFERENCE: 2026095-2015-00132/15-00328(B). FILL VOLUME: 270ML. FLOW RATE: 5ML/HR. REPORT #1 OF 2: IT WAS REPORTED THAT A PUMP'S INFUSIONS ENDED SOONER THAN EXPECTED. IT WAS REPORTED AS, "WE HAVE HAD A COUPLE REPORTS FROM PTS. AT HOME THAT HAVE SAID ON POD#1 THAT THEIR ONQ PUMP WAS EMPTY, SO THEY REMOVED IT." THE INFUSION WAS EXPECTED TO RUN FOR APPROXIMATELY 54 HOURS. ADDITIONAL INFORMATION WAS REQUESTED, HOWEVER IS NOT AVAILABLE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    260472 ON-Q PUMP 270ML, 5ML/HR ELASTOMERIC PUMP MEB HALYARD - IRVINE P270X5 NI

    Patients

    Seq Age Sex Outcome Treatment
    1