BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MITEK FMS DUO PUMP

    MDR report key: 2060871 · Received March 11, 2011

    Report

    Report Number
    1221934-2011-00104
    Event Type
    Malfunction
    Date Received
    March 11, 2011
    Date of Event
    March 3, 2011
    Report Date
    March 7, 2011
    Manufacturer
    DEPUY MITEK
    Product Code
    HRX
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    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 THAT DURING AN ARTHROSCOPIC KNEE REPAIR, WITH THE USE OF AN FMS DUO PUMP FOR FLUID MANAGEMENT, THE PT'S LEG BECAME EXTRAVASATED. IT APPEARS THAT THE PUMP WAS RUNNING CONSTANTLY FOR AT LEAST 10 MINUTES: AT THIS POINT THE PT'S LEG "STARTED RISING" AND BECAME "ROCK HARD". THE STOPPED WHAT HE WAS DOING, HAD THE NURSE CHECK THE PUMP. THEY NOTED THAT THE FILL CHAMBER WAS FULL, THEY CHECKED ALL OF THE CONNECTIONS, AND THEY WERE ALL SECURE. THE SURGEON STOPPED THE REPAIR, LOOSENED THE TOURNIQUET, ALLOWED SOME TIME FOR THE LEG TO SOFTEN, SWITCHED TO ANOTHER PUMP AND CONTINUED THE REPAIR SUCCESSFULLY WITHOUT FURTHER ISSUE OR HARM TO THE PT. PROCEDURE WAS EXTENDED BY 30 MINUTES. THE PT WAS SENT HOME AND RECEIVED A FOLLOW UP CALL THE NEXT DAY AND REPORTS NO ISSUES.

    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