BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MITEK FMS DUO PUMP

    MDR report key: 1993883 · Received February 14, 2011

    Report

    Report Number
    1221934-2011-00052
    Event Type
    Injury
    Date Received
    February 14, 2011
    Date of Event
    February 7, 2011
    Report Date
    February 8, 2011
    Manufacturer
    DEPUY MITEK
    Product Code
    HRX
    Removal / Correction Number
    NA
    Adverse Event
    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 F/U REPORT.

    Description of Event or Problem · 1

    IT WAS REPORTED BY THE SALES REP THAT A PT UNDERWENT A SUCCESSFUL ARTHROSCOPIC HIP PROCEDURE WITH THE USE OF AN FMS PUMP FOR FLUID MANAGEMENT. THE SALES REP STATED DURING THE PROCEDURE, THE SURGEON STARTED THE PUMP AT A PRESSURE SETTING OF 45 AND INCREASED DURING THE PROCEDURE TO 60. NO ISSUES WERE NOTICED DURING THE PROCEDURE. FOLLOWING THE SURGERY, THE PT WAS MOVED TO RECOVERY, AND UPON WAKING FROM RECOVERY, THE PT COMPLAINED OF ABDOMINAL PAIN. AT THIS POINT, THE ANESTHESIOLOGIST DIAGNOSED THAT THERE WAS FLUID IN THE ABDOMEN AND THE PT WAS ADMITTED TO THE HOSPITAL FOR OBSERVATION. THE FLUID DISSIPATED PASSIVELY, NO INTERVENTION WAS NEEDED. AT THIS POINT IN TIME, WE ARE AWAITING FURTHER INFO FROM THE FACILITY.

    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 Required Intervention