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Patient 1
ASP INVESTIGATION SUMMARY: THE INVESTIGATION INCLUDED A SERVICE HISTORY REVIEW, COMPLAINT TRENDING BY PROBLEM CODE, FAILURE MODE AND EFFECTS ANALYSIS, SYSTEM HAZARD AND USER MISUSE ANALYSIS AND HEALTH HAZARD EVALUATION. THE DHR FOR THIS AER UNIT WAS NOT REVIEWED AS THE ROOT CAUSE WAS DETERMINED TO BE USE ERROR AND NOT MANUFACTURING RELATED. WITHIN THE PAST SIX MONTHS ((B)(4) 2009 - (B)(4) 2009), THIS UNIT, PER ACCOUNT HISTORY, DOES NOT SHOW ANY SIMILAR ISSUES DUE TO INCORRECTLY SETTING THE DISINFECT TIME ON THE AER UNIT. THUS, THERE IS NOT A SIGNIFICANT TREND. A REVIEW OF THE COMPLAINT HISTORY FOR AER UNITS WITH PROBLEM CODE "E09-DISFECTANT TIME NOT ENTERED" DID NOT REVEAL A SIGNIFICANT TREND OVER THE PAST 12 MONTHS ((B)(4) 2009 - (B)(4) 2010). AN ASSESSMENT OF THE AER FMEA (FAILURE MODE AND EFFECTS ANALYSIS) REVEALED THE RPN (RISK PRIORITY NUMBER) FOR HIGH LEVEL DISINFECT CYCLE TIME RELATED FAILURE MODE IS BELOW THE THRESHOLD OF 100, INDICATING THAT THE ASSOCIATED RISK IS MINIMAL. AN ASSESSMENT OF THE CIDEX OPA SOLUTION FMEA (FAILURE MODE AND EFFECTS ANALYSIS) REVEALED THE RPN (RISK PRIORITY NUMBER) FOR INSUFFICIENT EXPOSURE TIME IS BELOW THE THRESHOLD OF 100, INDICATING THAT THE ASSOCIATED RISK IS MINIMAL. THE CIDEX OPA SOLUTION/DISOPA SHUMA (SYSTEM HAZARD AND USER MISUSE ANALYSIS) WAS REVIEWED AND IT WAS DETERMINED THAT THE RISK DUE TO IMPROPER SOAKING IS A CATEGORY II - ALARP (AS LOW AS REASONABLY PRACTICABLE). THE HHE (HEALTH HAZARD EVALUATION) WAS REVIEWED FOR SIMILAR ISSUES OF A SHORTER DISINFECT TIME ON THE AER AND THE HAZARD/RISK INDEX WAS 6, WHICH INDICATES THE ASSOCIATED RISK IS LOW. THE ROOT CAUSE WAS DETERMINED TO BE USE ERROR OF INCORRECTLY SETTING THE DISINFECT TIME ON THE AER UNIT. UPON FOLLOW-UP, THE CUSTOMER STATED THAT THE AER WAS NO LONGER IN SERVICE. THE CUSTOMER REFUSED TO PROVIDE ANY FURTHER INFORMATION. A LETTER WAS SENT TO THE CUSTOMER RECOMMENDING THEY REVIEW THE IFU (INSTRUCTIONS FOR USE) FOR THEIR DISINFECTANT OF CHOICE AND TO FOLLOW ALL DIRECTIONS FOR USE.