BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MITEK FMS DUO PUMP

    MDR report key: 2781373 · Received October 10, 2012

    Report

    Report Number
    1221934-2012-00262
    Event Type
    Injury
    Date Received
    October 10, 2012
    Date of Event
    September 10, 2012
    Report Date
    September 11, 2012
    Manufacturer
    DEPUY MITEK
    Product Code
    HRX
    PMA / PMN Number
    K954465
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    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.

    Additional Manufacturer Narrative · 1

    THE COMPLAINT DEVICE WAS RECEIVED AND EVALUATED. UPON RECEIPT, THE DEVICE WAS GIVEN A THOROUGH VISUAL AND FUNCTIONAL EXAMINATION. THE 1ST PORTION OF THE EXAMINATION WAS VISUAL: THIS VISUAL IS PERFORMED AS A MATTER OF COURSE TO DISCERN IF THE DEVICE HAS ANY OBVIOUS PHYSICAL DAMAGE, SOMETHING THAT MAY OR COULD HAVE BEEN A FACTOR IN CONTRIBUTING TO THE REPORTED EVENT; IT IS NOTED THAT THE DEVICE WAS RECEIVED IN GOOD PHYSICAL CONDITION. THE 2ND PORTION OF THE EXAMINATION WAS THE FUNCTIONAL AND ELECTRICAL TESTING: A BATTERY OF TESTS WAS PERFORMED TO ASSESS THE DEVICE'S OPERATIONAL STATUS. FUNCTIONALLY AND ELECTRONICALLY, THE DEVICE PERFORMED WELL WITHIN ITS DESIGN AND MANUFACTURED PARAMETERS; THE UNIT PASSED ALL DIAGNOSTIC TESTS, FUNCTIONAL TESTS, AND IS FULLY OPERATIONAL, NO FAULT OR PERFORMANCE ANOMALY COULD BE FOUND WITH THE FMS PUMP. THE ROOT OR UNDERLYING CAUSE FOR THE REPORTED EVENT IS NOT ATTRIBUTABLE TO THE FMS PUMP, BUT LIES ELSEWHERE. 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 SHOULDER REPAIR WITH THE USE OF A MITEK FMS DUO PUMP FOR FLUID MANAGEMENT, THE PUMP, UNCONTROLLABLY AND WITHOUT WARNING, FILLED THE JOINT SPACE WITH FLUID. THE PATIENT'S SHOULDER WAS DRAMATICALLY INCREASED IN SIZE. THE PROCEDURE WAS ABANDONED BECAUSE OF THIS. THIS IS ALL OF THE INFORMATION THAT HAS BEEN MADE AVAILABLE TO MITEK AT THIS TIME.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Other