THE CUSTOMER ALLEGED THE TEMPERATURE OF THE WATER WAS VERY HOT. THE CUSTOMER WAS CONCERNED ABOUT DAMAGING THE SCOPES. THE CUSTOMER DID NOT KNOW THE TEMPERATURE OF THE DISINFECTANT SOLUTION AND WAS ALSO UNAWARE OF THE AMBIENT TEMPERATURE INSIDE THE UNIT. IN ADDITION, THE CUSTOMER STATED THE UNIT WAS TURNED OFF IN THE MIDDLE OF THE CYCLE AND THE TEMPERATURE OF THE FLUID WAS 127 DEGREES FAHRENHEIT. THERE WAS CONDENSATION INSIDE THE UNIT. THE CUSTOMER STATED THE FUMES FROM THE DISINFECTANT MADE HIM DIZZY. THE CUSTOMER STATED THE ROOM WAS SMALL AND DID NOT HAVE GOOD VENTILATION. SUBSEQUENTLY, THE CUSTOMER STATED FOUR HEALTHCARE WORKERS EXPERIENCED ADVERSE EFFECTS FROM THE CIDEX OPA FUMES. THE FIRST HEALTHCARE WORKER EXPERIENCED "DRY THROAT, SHORTNESS OF BREATH, CONFUSION/SLOWED THOUGHT PROCESS, BURNING EYES, NASAL SYMPTOMS, HYPERTENSION, AND TACHYCARDIA" FOR A DURATION OF 1-3 HOURS. THE HEALTHCARE WORKER WAS ADMITTED TO THE ER AND WAS LATER DISCHARGED. THE ROOM WAS EVACUATED SHORTLY AFTER. THE CUSTOMER LATER STATED, THE HEALTHCARE WORKER HAD COMPLETELY RECOVERED FROM THE SYMPTOMS AND RETURNED TO WORK. AN ASP FIELD SERVICE ENGINEER (FSE) IS SCHEDULED TO ASSESS THE UNIT ON SITE.
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Patient 1
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EYES, NOSTRIL; DRY THROAT, SHORTNESS OF BREATH. CAPITAL EQUIPMENT WILL BE EVALUATED AT THE CUSTOMER SITE. ALL RELATED MDRS: 2150060-2010-00003, 2150060-2010-00004, 2150060-2010-00005.
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Patient 1
ASP INVESTIGATION SUMMARY: THE INVESTIGATION INCLUDED A SERVICE HISTORY REVIEW, COMPLAINT TRENDING BY PROBLEM CODE, SYSTEM HAZARD USE AND MISUSE ANALYSIS, FAILURE MODE AND EFFECTS ANALYSIS, HEALTH HAZARD EVALUATION AND CORRECTIVE AND PREVENTATIVE ACTION. A REVIEW OF THE SERVICE HISTORY FOR THIS AER UNIT FOR SIX MONTHS, (B)(6) 2009, SHOWS NO SIMILAR HR ISSUES AND THERE ARE NO TRENDS WITH THE AER UNIT EMITTING BURNING ODOR OR FUMES. THE AER CPUY (COMPLAINTS PER UNIT YEAR) WAS REVIEWED FROM (B)(6) 2009 THROUGH (B)(6) 2010 FOR PMCS (PROBLEM MALFUNCTION CODES): "HR- EYE BURNING" AND "HR-ALLERGIC SYMPTOMS". CPUY HR-EYE BURNING: THE CPUY TREND DROPS INITIALLY AND INCREASES FROM (B)(6) 2009 TO (B)(6) 2009. THE TREND LINE PEAKS FOR (B)(6) 2009 SLIGHTLY ABOVE THE UCL (UPPER CONTROL LIMIT). THE TREND LINE DECREASES SIGNIFICANTLY AFTER (B)(6) 2009 AND LEVELS OUT AND STAYS BELOW THE UCL OVERALL. CPUY HR-ALLERGIC SYMPTOMS: THE CPUY TREND LINE INCREASES AND EQUALS THE UCL FOR (B)(6) 2009. THE TREND LINE DECREASES AFTER (B)(6) 2009 AND PEAKS AGAIN FOR (B)(6) 2010 BUT STAYS BELOW UCL. IT DECREASES SIGNIFICANTLY AFTER (B)(6) 2010. THE CIDEX OPA SOLUTION/DISOPA SHUMA (SYSTEM HAZARD USE AND MISUSE ANALYSIS) WAS REVIEWED AND IT WAS DETERMINED THAT THE RISKS ASSOCIATED WITH CIDEX EXPOSURE ARE ALL CATEGORY II AND ARE MODERATE. AN ASSESSMENT OF THE CIDEX OPA SOLUTION FMEA (FAILURE MODE AND EFFECTS ANALYSIS) REVEALED THE RPN (RISK PRIORITY NUMBER) FOR HR-EYE EXPOSURE IS BELOW THE THRESHOLD OF 100. THE HHE (HEALTH HAZARD EVALUATION) WAS COMPLETED AND THE RISK ASSOCIATED WITH SUCH FAILURES WAS FOUND TO BE MODERATE. A CAPA (CORRECTIVE AND PREVENTATIVE ACTION) HAS BEEN OPENED TO ADDRESS THE ISSUE OF AER NOT SHUTTING OFF AT THE APPROPRIATE TEMPERATURE DUE TO FAILURE OF THE THERMISTOR, TEMPERATURE SENSOR HARNESS AND/OR MICROPROCESSOR BOARD. THE CONCOMITANT PRODUCT IS GASEOUS FUMES AND ODOR FROM CIDEX OPA SOLUTION. AN ASP AE (ACCOUNT EXECUTIVE) AND A MINNTECH (THE EXTERNAL MANUFACTURER) TECHNICIAN CHECKED THE AER UNIT WHICH WAS LOCKED UP AT A STORAGE SITE AT THE FACILITY. THE FOLLOWING ISSUES WERE IDENTIFIED: THE CIDEX OPA WAS OVERHEATING. THE TEMPERATURE LIGHT WAS NOT COMING ON. THE HEATER WAS NOT SHUTTING OFF. THE TEMPERATURE WAS RECORDED TO BE 89? F AND WAS INCREASING. A BAD CONNECTION TO THE BOARD WAS FOUND. THE ROOT CAUSE FOR THE AER UNIT OVERHEATING IS KNOWN TO BE FAILURE OF THE THERMISTOR, TEMPERATURE SENSOR HARNESS AND/OR MICROPROCESSOR BOARD. A FOLLOW UP WITH THE CUSTOMER INDICATED THAT THE AER UNIT WAS TAKEN OUT OF SERVICE AND WAS SHIPPED TO MINNTECH.
AMSCO 600 Steam Sterilizer, V-PRO maX 2 Low Temperature Sterilization System, V-PRO s2 Low Temperature Sterilization System, V-PRO 60 Low Temperature Sterilization System, RAS 12 Rack, RAS 12 Long Rack, RAS Cycle of the AMSCO 7052HP and 7053HP Single Chamber Washer Disinfector
AMSCO 600 Steam Sterilizer, V-PRO maX 2 Low Temperature Sterilization System, V-PRO s2 Low Temperature Sterilization System, RAS 12 Rack, RAS 12 Long Rack, RAS Cycle of the AMSCO 7052HP and 7053HP Single Chamber Washer Disinfector