BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ASP AUTOMATIC ENDOSCOPE REPROCESSOR

    MDR report key: 1953239 · Received January 7, 2011

    Report

    Report Number
    2150060-2010-00083
    Event Type
    Malfunction
    Date Received
    January 7, 2011
    Date of Event
    July 15, 2009
    Report Date
    August 3, 2009
    Manufacturer
    MINNTECH CORPORATION
    Product Code
    KOG
    PMA / PMN Number
    K832458
    Removal / Correction Number
    Z-0628-2011
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    AFTER THE INITIAL MEDWATCH REPORT, 2150060-2010-00083 (REPLACEMENT FOR MEDWATCH 2084725-2009-00490) WAS SUBMITTED, ADDITIONAL INVESTIGATION WAS CONDUCTED. THE CPUY (COMPLAINTS PER UNIT YEAR) FOR THE PROBLEM "HR-EYE REACTION" WAS COMPLETED FOR (B)(4) 2010 THROUGH (B)(4) 2010 AND NO SIGNIFICANT TREND WAS NOTED. CIDEX OPA IS A CONCOMITANT PRODUCT. HOWEVER, THE LOT/BATCH NUMBER OF THE CIDEX OPA WAS UNKNOWN; THEREFORE, THE CERTIFICATE OF ANALYSIS COULD NOT BE REVIEWED.

    Additional Manufacturer Narrative · 1

    (B)(4): TRANSITORY EYE IRRITATION. (B)(4): CAPITAL EQUIPMENT EVALUATED AT THE CUSTOMER SITE. THE FIELD SERVICE ENGINEER (FSE) REPORTED THAT CONTROLLER BOARD FAILED CAUSING THE CIDEX OPA HEATER TO STAY ON. THIS HEATED THE CIDEX OPA SOLUTION CREATING A STEAM THAT WAS IRRITATING TO THE EYES. THE ACTUAL TEMPERATURE OF THE CIDEX OPA WAS HOT BUT MOST LIKELY NOT 250 F AS THE CUSTOMER CLAIMED. THE SOLUTION WAS HOT, BUT NOT VISIBLY BOILING. THE UNIT WAS PUT UP FOR SERVICE. THE FSE REPLACED THE CONTROLLER BOARD AND ALSO ORDERED THE NEW STYLE OPA RESERVOIR AND REPLACED THE OPA RESERVOIR AND HEATER FOR BOTH UNITS. THE NEW STYLE TANK AND HEATER WILL PREVENT OVERHEATING FROM RECURRING. ASP INVESTIGATION SUMMARY: THE INVESTIGATION INCLUDED SERVICE HISTORY REVIEW, COMPLAINT TRENDING BY PROBLEM CODE, FAILURE MODE AND EFFECTS ANALYSIS, HEALTH HAZARD EVALUATION, AND SYSTEM HAZARD AND USER MISUSE ANALYSIS. REVIEW OF THE SERVICE HISTORY FROM (B)(6) 2010 OF THIS AER UNIT WAS COMPLETED AND THE FOLLOWING TRENDS WERE FOUND: THERE IS A TREND WITH THE CONTROLLER BOARD/ PWA MICROPROCESSOR REPLACED MORE THAN THREE TIMES IN SIX MONTHS ON (B)(6) 2009 AND AS REPORTED FOR THIS ISSUE ON (B)(6) 2009. HENCE THE TREND IS CONSIDERED SIGNIFICANT. THERE IS ONE SIMILAR HUMAN REACTIONS, "HR-EYE SPLASH" ISSUE REPORTED ON (B)(6) 2009 FOR WHICH THE PWA MICROPROCESSOR WAS REPLACED. ON (B)(6) 2010, ASP SENT A HEATER DISCONNECTION LETTER, TO THE CUSTOMER, AS PART OF FIELD CORRECTION, IN ORDER FOR THE FACILITY TO DISCONNECT THE HEATER FROM THE AER UNIT AND AVOID OVER HEATING ISSUES. AER CPUY (COMPLAINT PER UNIT YEAR) TREND CHART FOR PROBLEM CODE "HR-EYE REACTION" FROM (B)(6) 2009 THROUGH (B)(6) 2010 WAS COMPLETED. THE TREND LINE LIES BELOW THE UCL FOR ALL TWELVE MONTHS. THE TREND LINE AND THE CPUY VALUES ARE HIGH FROM (B)(6) 2010 AND DECREASE AFTER (B)(6) 2010. THE FMEA (FAILURE MODE AND EFFECTS ANALYSIS) WAS REVIEWED AND THE OVERALL RISK PRIORITY NUMBERS DUE TO FAILURES TO THE CONTROLLER ARE BELOW 100. FAILURES TO THE REPLACED TANK WITH HEATER HAVE RPNS GREATER THAN 100 FOR WHICH A FIELD CORRECTION DISCONNECTING THE HEATER WAS IMPLEMENTED. AN ASSESSMENT OF THE CIDEX OPA SOLUTION FMEA REVEALED THE RISK PRIORITY NUMBER (RPN) FOR OVERHEATING IS BELOW THE THRESHOLD OF 100, INDICATING THAT THE ASSOCIATED RISK IS MINIMAL. THE HHE (HEALTH HAZARD EVALUATION) SHOWS THE SCORE FOR OVERHEATING IS 8 WHICH IS OF MODERATE RISK. THE CIDEX OPA SOLUTION/DISOPA SHUMA (SYSTEM HAZARD AND USER MISUSE ANALYSIS) WAS REVIEWED AND IT WAS DETERMINED THAT THE RISKS ASSOCIATED WITH HR-EYE EXPOSURE ARE ALL CATEGORY I WHICH IS CONSIDERED LOW RISK. TWO CAPAS (CORRECTIVE AND PREVENTIVE ACTION PLAN) WERE OPENED TO ADDRESS THE ISSUES OF OVERHEATING AND TANK REPLACEMENT. THE DISINFECTANT HEATING FUNCTION FAILS TO SHUT OFF AT THE CORRECT TEMPERATURE CAUSING OVERHEATING OF THE DISINFECTANT. THE OLD RESERVOIR TANK ASSEMBLY IS ASSEMBLED NOT MOLDED WHICH CAN CRACK AND MAY CAUSE LEAKS. THE SERVICE HISTORY SHOWS THAT THIS AER UNIT HAS NOT HAD THE TANK REPLACED SINCE THE INSTALLATION. THIS COMPLAINT REPLACES COMPLAINT (B)(4) WHICH WAS SUBMITTED UNDER THE INCORRECT MANUFACTURER REGISTRATION NUMBER. REFERENCE MDRS: 2150060-2010-00081- REPLACED 2084725-2009-00491, 2150060-2010-00083 - REPLACED 2084725-2009-00490, 2150060-2010-00084 - REPLACED 2084725-2009-00470.

    Description of Event or Problem · 1

    AN ADDITIONAL REPORT WAS RECEIVED FROM A FACILITY REGARDING THE HEATING OF THE CIDEX OPA IN THE AER. BESIDES THE INITIAL USER, THE CALLER REPORTED ANOTHER TECHNICIAN EXPERIENCED TRANSITORY EYE IRRITATION. AN ASP FIELD SERVICE ENGINEER (FSE) WENT TO THE FACILITY TO ASSESS THE UNIT. THE CUSTOMER LATER STATED THAT AER UNIT IS WORKING FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ASP AUTOMATIC ENDOSCOPE REPROCESSOR AER EQUIPMENT KOG MINNTECH CORPORATION NA

    Patients

    Seq Age Sex Outcome Treatment
    1 29 YR