FDA.reportPublic FDA data

MAUDE MDR 1545039

MDR report key
1545039
Report number
2150060-2009-00163
Event key
0
Event type
3
Date of event
2009-10-16
Date received
2009-11-12
Adverse event
3
Product problem
3
Patients in event
0
Reporter occupation
0
Health professional
3
Initial report to FDA
3
Event location
0

Manufacturer Contact#

Contact
GINNY STAMBERGER
Address
33 TECHNOLOGY DR IRVINE CA 92618 US
Phone
949-949-9497
Report source
M
Manufacturer link flag
Y

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1ASP AUTOMATIC ENDOSCOPE REPROCESSOR WITH PRINTERAER EQUIPMENTMINNTECH CORPNVENA20301NAR N

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12009-11-120

Event Narratives#

N

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 (DEVICE HISTORY RECORD) 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 DID 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-DISINFECTANT 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 NUMBERS) FOR ALL LEAK RELATED FAILURE MODES ARE BELOW THE THRESHOLD OF 100, INDICATING THAT THE ASSOCIATED RISKS ARE MINIMAL. THUS, NO FURTHER ACTION IS REQUIRED AT THIS TIME. 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); THEREFORE, NO FURTHER ACTION IS REQUIRED AT THIS TIME. THE HHE (HEALTH HAZARD EVALUATION) WAS REVIEWED FOR SIMILAR ISSUES OF A SHORTER DISINFECT TIME LEAK ON THE AER AND THE HAZARD/RISK INDEX WAS 6, WHICH INDICATES THE ASSOCIATED RISK IS LOW. DUE TO THE LOW HEALTH/RISK INDEX, NO FURTHER ACTION IS REQUIRED. THE ROOT CAUSE WAS DETERMINED TO BE USE ERROR OF INCORRECTLY SETTING THE DISINFECT TIME ON THE AER UNIT. THE CIDEX OPA SOLUTION IFU (INSTRUCTION FOR USE) STATES THAT MANUAL PROCESSING OF CIDEX OPA SOLUTION SHOULD BE DONE AT A MINIMUM OF 20 DEGREES C WITH AN IMMERSION TIME OF AT LEAST 12 MINUTES. CIDEX OPA SOLUTION CAN ALSO BE USED IN AERS THAT ARE SET TO A MINIMUM OF 25 DEGREES C WITH AN IMMERSION TIME OF AT LEAST 5 MINUTES. IF THE AER CANNOT BE SET TO A MINIMUM OF 25 DEGREES C, AND THEN THE TIME AND TEMPERATURE STATED IN THE IFU FOR MANUAL PROCESSING SHOULD BE FOLLOWED. IN THE CUSTOMER LETTER AND INSTRUCTIONS PACKAGE THAT ADDRESSES DISCONNECTING THE AER HEATER, IT STATES THE FOLLOWING: "CIDEX OPA SOLUTION USERS: IF YOU ARE USING CIDEX OPA SOLUTION, YOU MUST DISCONNECT THE HEATER AND USE THE CIDEX OPA SOLUTION IN ACCORDANCE WITH ITS LABEL DIRECTIONS OF 12 MINUTE IMMERSION TIME AT 20 DEGREES C. THE HEATER CAN BE DISCONNECTED BY HAVING YOUR TECHNICIAN FOLLOW THE ENCLOSED INSTRUCTIONS. ASP RECOMMENDS THAT THE USER CHECK THE SOLUTION TEMPERATURE IN THE BASIN ON A REGULAR BASIS PER INSTITUTIONAL GUIDELINES." IT WAS CONFIRMED THAT THE CUSTOMER RECEIVED THE CUSTOMER LETTER AND INSTRUCTIONS PACKAGE IN REGARDS TO DISCONNECTING THE AER HEATER ON (B)(4), 2010. UPON FOLLOW-UP, THE CUSTOMER CONFIRMED THAT THE SOAK TIME WAS CHANGED BY THE ASP CEC (CLINICAL EDUCATION CONSULTANT) AND THAT THE UNIT AS IN USE.

D

Patient 1

AN ASP CLINICAL EDUCATION CONSULTANT (CEC) DISCOVERED AND REPORTED THE AER'S DISINFECT TIME WAS SET AT FOUR MINUTES AS OPPOSED TO FIVE MINUTES. THE CEC CHANGED THE DISINFECT CYCLE TO THE CORRECT SOAK TIME OF FIVE MINUTES. THE CUSTOMER DID NOT KNOW HOW LONG IT WAS SET AT FOUR MINUTES. THE FACILITY HAD NOT REPORTED ANY INFECTIONS OR HUMAN REACTIONS. ADVANCED STERILIZATION PRODUCTS (ASP) LATER CONTACTED THE CUSTOMER AND SHE STATED: THE DISINFECT TIME WAS SET AT FOUR MINUTES SINCE ITS INSTALLATION; NO SINGLE CASE OR INFECTIONS TO DATE; NO DOCUMENT CASES FOR ANY ADVERSE REACTIONS AFTER THE COLONOSCOPY PROCEDURE; THE FACILITY PERFORMS A 24-HOUR POST-OPERATIVE CALL TO ALL PATIENT'S; THE FACILITY PERFORMS A FULL 15-30 DAY POST-PROCEDURE INFECTION RATE MONITORING -ALL YIELDED NEGATIVE; THE FACILITY ONLY ADMINISTERS COLONOSCOPIES; THE FACILITY USES COLONOSCOPES; AND THE CEC CORRECTLY UPDATED THE DISINFECT TIME TO FIVE MINUTES. THE UNIT IS IN FULL OPERATION.

N

Patient 1

IF ANY PATIENT OR ADDITIONAL INFORMATION IS OBTAINED FROM THE CUSTOMER WITH REGARDS TO PATIENT COMPLICATION, AN ADDITIONAL FDA MEDWATCH FORM(S) WILL BE SUBMITTED ACCORDINGLY.