BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MITEK FMS DUO PUMP

    MDR report key: 2853131 · Received November 30, 2012

    Report

    Report Number
    1221934-2012-00322
    Event Type
    Injury
    Date Received
    November 30, 2012
    Date of Event
    July 20, 2012
    Report Date
    November 8, 2012
    Manufacturer
    DEPUY MITEK
    Product Code
    HRX
    PMA / PMN Number
    K954465
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SW
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    MITEK IS AT THIS POINT IN TIME IN THE INFORMATION 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. AWAITING RETURN.

    Additional Manufacturer Narrative · 1

    SIXTY-THREE DAYS HAVE PASSED SINCE THIS ISSUE WAS REPORTED TO MITEK, AND TO DATE, DESPITE MANY OUTREACHES FOR FURTHER DETAIL AND COMPLAINT DEVICE RETURN; THE STATUS AND THE LOCATION OF THE COMPLAINT DEVICE IS UNKNOWN TO US, AND NO ADDITIONAL SUBSTANTIAL INFORMATION OTHER THAN WHAT WAS ORIGINALLY REPORTED HAS BEEN RECEIVED. WE CANNOT TELL ANYTHING FROM THIS, WE CANNOT DISCERN THE ROOT OR UNDERLYING CAUSE FOR THE REPORTED ISSUE. AT THIS POINT IN TIME, NO FURTHER ACTION IS WARRANTED. HOWEVER, THIS FILE WILL REMAIN RECEPTIVE TO ANY POTENTIAL FORTHCOMING INFORMATION RECEIVED THAT IS PERTINENT AND GERMANE TO THIS ISSUE. ALSO, MITEK WILL CONTINUE TO TRACK ANY RELATED COMPLAINTS WITHIN THIS DEVICE FAMILY AS A MEANS OF MONITORING THE EXTENT WITH WHICH THIS COMPLAINT IS OBSERVED IN THE FIELD.

    Additional Manufacturer Narrative · 1

    THIS ISSUE TOOK PLACE ON (B)(6) 2012 AND WAS REPORTED TO US ON (B)(4) 2012. THE DEVICE REMAINED IN SERVICE WITHOUT ANY FURTHER REPORTED ISSUE AND SO THE COMPLAINT WAS CLOSED OUT ON (B)(4) 2013, 63 DAYS LATER. IT IS NOT CLEAR TO US WHERE THIS DEVICE HAS BEEN SINCE THIS TIME; HOWEVER, ITS REQUEST FOR QUALIFIED SERVICE CAME TO US ON OR AROUND (B)(4) 2013. THE ORIGINAL COMPLAINT HAS BEEN RE-OPENED AND THE DEVICE HAS BEEN EVALUATED AT A PROPERLY QUALIFIED SERVICE CENTER. THE SERVICE CENTER FOUND THAT THE DEVICE HAD SOME COMPONENT ANOMALIES; A GUIDE LINE WAS BENT AND THE PRESSURE ADJUSTERS WERE WORN OUT, ALTHOUGH THESE DEFECTS WERE PRESENT THE SERVICE CENTER COULD NOT DUPLICATE THE REPORTED PROBLEM. THE DEVICE WAS REPAIRED AND RETURNED TO THE OWNER FACILITY. GIVEN THE FACT THAT THIS DEVICE HAS BEEN IN USE FOR ALMOST A YEAR BEFORE ITS SERVICE EVALUATION, AND THE SERVICE CENTER COULD NOT REPLICATE THE REPORTED ISSUE, WE CANNOT ATTRIBUTE THE DEVICE DEFECTS TO THE REPORTED HISTORICAL EVENT. WE CANNOT TELL ANYTHING FROM THIS AND OUTSIDE OF THE POSSIBILITY THAT USER TECHNIQUE WAS THE DRIVER FOR THE EVENT; WE CANNOT DISCERN ANY ROOT OR UNDERLYING CAUSE FOR THE REPORTED ISSUE. AT THIS POINT IN TIME, NO FURTHER ACTION IS WARRANTED. HOWEVER, THIS FILE WILL REMAIN RECEPTIVE TO ANY POTENTIAL FORTHCOMING INFORMATION RECEIVED THAT IS PERTINENT AND GERMANE TO THIS ISSUE. ALSO, MITEK WILL CONTINUE TO TRACK ANY RELATED COMPLAINTS WITHIN THIS DEVICE FAMILY AS A MEANS OF MONITORING THE EXTENT WITH WHICH THIS COMPLAINT IS OBSERVED IN THE FIELD.

    Description of Event or Problem · 1

    OUR AFFILIATE IS REPORTING TO US THAT DURING AN ARTHROSCOPIC KNEE PROCEDURE WITH THE USE OF AN FMS DUO PUMP FOR FLUID MANAGEMENT, THE PATIENT EXPERIENCED EXTRAVASATION TO THE THIGH THAT REQUIRED A FASCIECTOMY FOR REMEDY. IT APPEARS THAT DURING THE SURGERY, THE FILL CHAMBER ON THE PUMP BECAME OVER FILLED, THE STAFF EMPTIED THE CHAMBER AND FOR WHATEVER REASON, ATTEMPTED TO RE-USE AND THEY REPEATEDLY PRESS THE RUN/STOP SWITCH AND DROVE THE PRESSURE TO OVER 100. THE SURGERY COMMENCED AT 3:40 AND CONCLUDED AT 4:46; THE FASCIECTOMY COMMENCED AT 5:47 AND CONCLUDED AT 6:12. THE PATIENT HAS RECOVERED AND IS IN GOOD CONDITION. THE DEVICE HAS BEEN USED SINCE THIS INCIDENT WITHOUT ISSUES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MITEK FMS DUO PUMP FLUID MANAGEMENT SYSTEM HRX DEPUY MITEK NA 0537F2529

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention