BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    1142 INTERMED TUBESET S/CHKVLVE PK/24-SH

    MDR report key: 3940307 · Received July 17, 2014

    Report

    Report Number
    1221934-2014-00306
    Event Type
    Malfunction
    Date Received
    July 17, 2014
    Date of Event
    May 1, 2013
    Report Date
    June 19, 2014
    Manufacturer
    DEPUY MITEK
    Product Code
    HRX
    PMA / PMN Number
    K951843
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    BACKGROUND: THE FMS SYSTEM SUPPORTS JOINT ACCESS AND VISUALIZATION THROUGH FLUID IRRIGATION DURING ARTHROSCOPIC PROCEDURES. IN THE O.R., IRRIGATION FLUID FLOWS FROM SALINE BAGS THROUGH A MULTIUSE ¿DAY SET¿ TO TREAT MULTIPLE (APPROXIMATELY 5 PATIENTS) ON ANY GIVEN DAY. FORWARD FLOW OF FLUID IS CONTROLLED BY THE DEVICES ROTATORS & ROCKER ARM AND PRESSURE SENSOR LINE (WHICH SHUTS-OFF THE DEVICE IF PRESSURE FALLS). IF THESE CONTROLS FAIL, THE ¿ONE WAY¿ PILLOW VALVE BETWEEN THE DAY SET & PATIENT SET, ACTS AS A BACK UP SAFETY VALVE TO PREVENT BACKFLOW/CROSS CONTAMINATION ISSUE: INTERNAL TESTING IDENTIFIED THAT A NEW LOT OF PILLOW VALVES MAY NOT BE PERFORMING AS INTENDED (I.E. PILLOW VALVES ARE OPEN). POTENTIAL RISKS AT THAT TIME: BACKFLOW OF IRRIGATION FLUID MAY CAUSE EXCHANGE OF HUMAN BODY FLUIDS RESULTING IN CROSS CONTAMINATION AND POTENTIAL TRANSMISSION OF BACTERIAL, FUNGAL, OR VIRAL INFECTIONS TO SUBSEQUENT SURGERY PATIENTS ON THAT DAY. EXPOSURE TO PRIONS, OTHER PROTEINS AND HUMAN ANTIGENIC MATERIAL IS ALSO POSSIBLE. SUCH BACTERIAL AND FUNGAL INFECTIONS ARE USUALLY DETECTED EARLY AND POTENTIALLY TREATABLE IN MOST CASES, HOWEVER, SERIOUS VIRAL INFECTIONS (FOR EXAMPLE HIV, HEP B, HEP C) HAVE LONGER LATENCY, ARE MORE DIFFICULT TO TREAT AND MAY BE LIFE THREATENING. THERE HAVE BEEN NO REPORTS OF CROSS-CONTAMINATION OR INFECTIONS RELATED TO THIS ISSUE TO DATE. ACTIONS TAKEN IN 2013: INITIATED A WORLDWIDE STOP SURGERY AND RECALL FOR AFFECTED TUBING AND PLACED MANUFACTURING OF ALL TUBING ON TEMPORARY HOLD. CROSS CONTAMINATION RISK ASSESSMENT MODEL - RISK OF SERIOUS VIRAL INFECTIONS: WE DEVELOPED A WORST-CASE SCENARIO PATIENT RISK MODEL WITH GUIDANCE FROM DR. (B)(6). DR. (B)(6), PROF OF MEDICINE, DEPT OF INFECTIOUS DISEASES, (B)(6) SCHOOL OF MEDICINE. DR. (B)(6), DIVISION OF INFECTIOUS DISEASES, UNIVERSITY OF (B)(6). (B)(4) TUBE SETS DISTRIBUTED. ~(B)(4)% BASED ON INTERNAL LAB TESTING MAY HAVE NONFUNCTIONING VALVES (=(B)(4)TUBES) ~(B)(4)% BASED ON 2 X ACTUAL COMPLAINT RATES MAY EXPERIENCE BACK FLOW SITUATION (=(B)(4)TUBES). ~(B)(4)% BASED ON CDC PREVALENCE RATES MAY HAVE BEEN USED IN A PATIENT WITH SERIOUS VIRAL INFECTIONS (=(B)(4)TUBES). THE METHODOLOGY AND RESULTS WERE REVIEWED BY EXTERNAL INFECTIOUS DISEASE EXPERTS (DR. (B)(6)) AS WELL AS BY OUR INTERNAL TEAMS. THEIR OVERALL ASSESSMENT WAS THAT THE RISK OF CROSS-CONTAMINATION IS VERY LOW. THE CONCERNED PATIENT IN THIS COMPLAINT HAS NOT DEVELOPED ANY INFECTION IN THE LAST 13 MONTHS AND THEREFORE THE FUTURE RISK IS DETERMINED TO BE VERY LOW. NO FURTHER ACTIONS ARE WARRANTED AT THIS TIME. HOWEVER, DEPUY 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

    THE CUSTOMER'S INFECTION CONTROL REPRESENTATIVE REPORTED THAT IN (B)(6) 2013 THAT THE INTERMEDIARY TUBING WAS NOT CHANGED BETWEEN PATIENTS DURING A KNEE REPAIR. THE DATE OF (B)(6) IS BEING USED SINCE THE SPECIFIC DATE WAS NOT GIVEN. THE REPRESENTATIVE REPORTED THAT THERE WERE NO PATIENT CONSEQUENCES AT THAT TIME AND NONE STILL. FULL DISCLOSURE WAS MADE TO THE PATIENT AT THE TIME OF THE INCIDENT. THE INCIDENT WAS NOT REPORTED TO US INITIALLY BECAUSE THE CUSTOMER STATED THERE WAS NO COMPLAINT SINCE IT WAS USER ERROR AND NOTHING AGAINST OR ANY FAILURE OF OUR PRODUCT. THE CUSTOMER CONTACTED US NOW JUST FOR FURTHER INFORMATION REGARDING THE POSSIBILITY OF CROSS CONTAMINATION AT THE PATIENTS REQUEST. THE CUSTOMER REPORTED THAT THE PATIENT IS STILL CONCERNED AT THIS TIME EVEN THOUGH NO ISSUES HAVE BEEN FOUND.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    420401 1142 INTERMED TUBESET S/CHKVLVE PK/24-SH FMS TUBING HRX DEPUY MITEK NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1