BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MITEK FMS DUO PUMP

    MDR report key: 2060870 · Received March 11, 2011

    Report

    Report Number
    1221934-2011-00105
    Event Type
    Malfunction
    Date Received
    March 11, 2011
    Date of Event
    March 4, 2011
    Report Date
    March 4, 2011
    Manufacturer
    DEPUY MITEK
    Product Code
    HRX
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    MITEK IS, AT THIS POINT IN TIME, IN THE INFO GATHERING MODE. WHEN ALL THAT CAN BE HAD, IS HAD AND THOROUGHLY INVESTIGATED AND EVALUATED, THOSE RESULTS WILL BE THE SUBJECT MATTER IN A FOLLOW-UP REPORT.

    Description of Event or Problem · 1

    OUR REP IS REPORTING TO US THAT DURING AN ARTHROSCOPIC KNEE REPAIR, WITH THE USE OF A MITEK FMS DUO PUMP FOR FLUID MANAGEMENT, THE PT'S LEG BECAME EXTRAVASATED; THEY SAY THAT THE UNIT WAS NOT READING PRESSURE CORRECTLY. THE SURGEON STOPPED WHAT THEY WERE DOING AND FOCUSED THEIR ATTENTION ON SQUEEZING AND MASSAGING THE PT'S LEG TO DISSIPATE THE FLUID. AFTER 30 MINUTES THE SURGEON RESUMED THE PROCEDURE AND COMPLETED THE CASE SUCCESSFULLY WITHOUT FURTHER ISSUE OR HARM TO THE PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MITEK FMS DUO PUMP FLUID MANAGEMENT SYSTEM HRX DEPUY MITEK 284580 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK