BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MITEK FMS DUO PLUS PUMP

    MDR report key: 3211591 · Received July 8, 2013

    Report

    Report Number
    1221934-2013-00171
    Event Type
    Malfunction
    Date Received
    July 8, 2013
    Date of Event
    June 10, 2013
    Report Date
    June 10, 2013
    Manufacturer
    DEPUY MITEK
    Product Code
    HRX
    PMA / PMN Number
    K954465
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPLAINT DEVICE WAS RECEIVED AND EVALUATED. UPON RECEIPT, THE DEVICE WAS GIVEN A THROUGH VISUAL AND FUNCTIONAL EXAMINATION. THE 1ST FAZE OF THE EXAMINATION WAS VISUAL. THIS VISUAL IS DONE 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 WITH PHYSICAL DAMAGE; SUCTION SAFETY COVER BROKEN OFF AND THE ROLLER PUMP HEAD PUSHED IN AGAINST THE FRONT PANEL; THIS TYPE OF DAMAGE IS INDICATIVE OF THE UNIT HAVING BEEN DROPPED. THE 2ND PORTION OF THE EXAMINATION WAS THE FUNCTIONAL TESTING. THIS PORTION OF THE EXAM IS PERFORMED TO ASSESS THE DEVICE¿S OPERATIONAL STATUS. AFTER CORRECTING THE PHYSICAL DAMAGE, ¿SAFETY COVER¿ REPLACED AND ¿ROLLER PUMP HEAD¿ RESEATED, THE DEVICE WAS ¿PERFORMANCE AND FUNCTIONAL¿ TESTED; THE PUMP PASSED ALL DIAGNOSTIC AND FUNCTIONAL TESTS WELL WITHIN ITS DESIGNED AND MANUFACTURED PARAMETERS. OUTSIDE OF THE PHYSICAL DAMAGE, WE COULD FIND NO OTHER FAULT OR ANOMALIES WITH THE DEVICE. IF THE DEVICE WAS IN USE IN THE RECEIVED CONDITION, WE WOULD ATTRIBUTE THE ROOT CAUSE TO ¿DAMAGE¿, HOWEVER, WE DO NOT KNOW AT WHICH POINT OR WHAT CONDITIONS THAT THE DEVICE SUSTAINED ITS DAMAGE, SO, FROM A PERFORMANCE POINT OF VIEW, WE CANNOT DISCERN A ROOT CAUSE FOR THE REPORTED ISSUE. AT THIS POINT IN TIME, NO CORRECTIVE OR FURTHER ACTION IS WARRANTED. HOWEVER, 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

    IT WAS REPORTED BY THE SALES REP THAT THE CUSTOMER STATED THAT THE PUMP WAS HYPER-FILLING THE JOINT. THE DOCTOR SIMPLY STATED THAT THE SHOULDER WAS EXTRAVASATED AND THE PUMP WAS CONTINUING TO PUT MORE PRESSURE IN THE JOINT. HE DID NOT DO ANYTHING TO THE SHOULDER TO REDUCE SWELLING. WE TURNED PRESSURE DOWN AND OUTFLOW WAS INCREASED, HOWEVER, THE PRESSURE DID NOT SEEM TO GO DOWN. IT WAS NOT A SITUATION HE DEEMED SEVERE OR NEEDED ANY ADDITIONAL ACTION. IT WAS NOT A SEVERE CASE OF EXTRAVASATION. CUSTOMER USED A SECOND PUMP TO COMPLETE THE PROCEDURE. NO PATIENT CONSEQUENCES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    309189 MITEK FMS DUO PLUS PUMP FLUID MANAGEMENT SYSTEM HRX DEPUY MITEK NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1