CIDEX® OPA SOLUTION
Report
- Report Number
- 2084725-2018-00686
- Event Type
- Malfunction
- Date Received
- August 30, 2018
- Date of Event
- August 8, 2018
- Report Date
- August 14, 2018
- Manufacturer
- ADVANCED STERILIZATION PRODUCTS
- Product Code
- MED
- UDI-DI
- 10705037000135
- PMA / PMN Number
- K032959
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TX
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
Narratives
AN ASP CLINICAL EDUCATION CONSULTANT CONFIRMED THE STAFF AT THE FACILITY HAS BEEN RE-TRAINED ON THE INSTRUCTIONS FOR USE (IFU) AND DISCARDING OF EXPIRED PRODUCT. IN ADDITION, IT WAS STATED THE AFFECTED SCOPES WERE NOT USED ON ANY PATIENTS. THE AFFECTED SCOPES WERE REPROCESSED AND THE EXPIRED CIDEX OPA SOLUTION WAS DISCARDED. (B)(4).
ASP INVESTIGATION SUMMARY: THE INVESTIGATION INCLUDED A REVIEW OF THE BATCH HISTORY RECORD, COMPLAINT TRENDING BY LOT NUMBER, AND SYSTEM RISK ANALYSIS (SRA). A REVIEW OF THE BATCH HISTORY SHOWS ALL THE REQUIRED PROCESS CHECKS ARE COMPLETE AND ACCEPTABLE. TEST SPECIFICATIONS FOR PRODUCT RELEASE WERE MET AND NO ISSUES WERE OBSERVED THAT WOULD CONTRIBUTE TO THE COMPLAINT ISSUE. A REVIEW OF THE LOT HISTORY FOR THE SIX MONTHS PRIOR TO OPEN DATE REVEALED TRENDING WAS NOT EXCEEDED. THE SRA SHOWS THE RISK FOR BIOHAZARDOUS, PATHOGENIC OR INFECTIOUS MATERIAL TO BE LOW. VISUAL ANALYSIS WAS NOT PERFORMED AS THE PRODUCT WAS NOT REQUIRED FOR RETURN. USER ERROR IS THE LIKELY ASSIGNABLE CAUSE OF THE REPORTED ISSUE. THE CUSTOMER ENTERED AN INCORRECT EXPIRATION DATE INTO THE EVOTECH REPROCESSOR. CUSTOMER RE-TRAINING WAS PERFORMED BY THE ASP CLINICAL EDUCATION CONSULTANT AND THE CUSTOMER WAS TOLD TO ALWAYS FOLLOWING THE IFU. THE ISSUE WILL CONTINUE TO BE TRACKED AND TRENDED. ASP COMPLAINT REF #: (B)(4).
AN ASP CLINICAL EDUCATION CONSULTANT CONFIRMED THE STAFF AT THE FACILITY HAS BEEN RE-TRAINED ON THE INSTRUCTIONS FOR USE (IFU) AND DISCARDING OF EXPIRED PRODUCT. IN ADDITION, IT WAS STATED THE AFFECTED SCOPES WERE NOT USED ON ANY PATIENTS. THE AFFECTED SCOPES WERE REPROCESSED AND THE EXPIRED CIDEX OPA SOLUTION WAS DISCARDED. (B)(4).
ASP COMPLAINT REF #: (B)(4).
IT WAS REPORTED BY AN ADVANCED STERILIZATION PRODUCTS (ASP) FIELD SERVICE ENGINEER (FSE) THAT WHILE ONSITE PERFORMING PLANNED MAINTENANCE ON THE CUSTOMER¿S EVOTECH® ECR, THE CUSTOMER WAS USING EXPIRED CIDEX® OPA SOLUTION IN THEIR EVOTECH® ECR. THE CUSTOMER ENTERED THE EXPIRATION DATE OF ENTERED SEPTEMBER 2018 INTO THE EVOTECH® ECR INSTEAD OF THE ACTUAL EXPIRATION DATE OF APRIL 2018. THE FSE WENT TO REPLACE THE CIDEX® OPA SOLUTION AND DISCOVERED THAT THE SOLUTION ON THE SHELF WAS ALSO EXPIRED. IT WAS NOTED, HOWEVER, THE SOLUTION WAS MEETING THE MINIMUM EFFECTIVE CONCENTRATION (MEC). A CONFERENCE CALL WAS INITIATED BY ASP AND THE FACILITY TO NOTIFY THEM OF THE ERROR. ALL ENDOSCOPES THAT WERE REPROCESSED DURING THIS TIME PERIOD WERE PULLED FROM THE SHELVES AND IT WAS DETERMINED BY THE FACILITY THAT SCOPES WERE USED ON 6 PATIENTS. THERE HAS BEEN NO REPORT OF ANY INFECTION OR INJURIES REPORTED TO DATE. HOWEVER, THE FACILITY IS TRACKING THESE PATIENTS. ASP WILL CONTINUE TO FOLLOW-UP AND IF NEW INFORMATION IS RECEIVED REGARDING A CHANGE IN THE PATIENT¿S STATUS, A SUPPLEMENTAL MEDWATCH REPORT WILL BE SUBMITTED. ASP HAS DECIDED TO REPORT CASES WHERE A CUSTOMER DOES NOT FOLLOW THE IFU WHEN PROCESSING THEIR SCOPES AND USED EXPIRED PRODUCT SINCE THE SCOPES CANNOT BE GUARANTEED TO HAVE BEEN HIGH-LEVEL DISINFECTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 675904 | CIDEX® OPA SOLUTION | BIOCIDES SOLUTIONS (MED) | MED | ADVANCED STERILIZATION PRODUCTS | 701200/004 | 10705037000135 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | EVOTECH® ECR SERIAL # (B)(4) |