BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MITEK FMS DUO PUMP

    MDR report key: 1181093 · Received September 29, 2008

    Report

    Report Number
    1221934-2008-00466
    Event Type
    Malfunction
    Date Received
    September 29, 2008
    Date of Event
    September 26, 2008
    Report Date
    September 26, 2008
    Manufacturer
    DEPUY MITEK
    Product Code
    HRX
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WV, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    MITEK IS AT THIS POINT IN TIME, AWAITING RECEIPT OF THE COMPLAINT DEVICE TOWARDS CONDUCTING A ROOT CAUSE FAILURE ANALYSIS, THE RESULTS OF WHICH WILL BE THE SUBJECT OF A FOLLOW-UP REPORT.

    Description of Event or Problem · 1

    THE FACILITY IS REPORTING THAT AT THE BEGINNING OF AN RC REPAIR, THE FMS PUMP WAS NOT MEASURING PRESSURE FLOW RATES CORRECTLY AND THE OUTFLOW WAS NOT WORKING. AS A RESULT, THE PATIENT'S SHOULDER BECAME EXCEEDINGLY SWOLLEN. BECAUSE OF THIS, THE SURGEON BECAME CONCERNED OVER THE PROBABILITY OF "COMPARTMENT SYNDROME" OCCURRING, IF HE CONTINUED ON. AT THIS POINT THE SURGEON ABANDONED REPAIRING THE ROTATOR CUFF AND INSTEAD PERFORMED A DEBRIDEMENT, A SUBACROMIAL DECOMPRESSION. THE SURGEON BELIEVES THAT THIS ALTERNATIVE MEANS OF RELIEVING THE PT'S ISSUE MAY WORK. THIS PROCEDURE WAS CONCLUDED SUCCESSFULLY WITHOUT FURTHER ISSUE OR HARM TO THE PT. DURING RECOVERY, THE FACILITY USED A DRAIN PUMP AS A PRECAUTION. THE PT WAS DISCHARGED UNDER NORMAL CIRCUMSTANCES WITHOUT ISSUE.

    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