BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CIDEX OPA CONCENTRATE

    MDR report key: 12861932 · Received November 23, 2021

    Report

    Report Number
    2084725-2021-00434
    Event Type
    Malfunction
    Date Received
    November 23, 2021
    Date of Event
    October 2, 2021
    Report Date
    December 21, 2021
    Manufacturer
    ADVANCED STERILIZATION PRODUCTS
    Product Code
    MED
    UDI-DI
    20705037000132
    PMA / PMN Number
    K032959
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    HI, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    CORRECTION - INCORRECT INFORMATION REPORTED IN BLOCK B5 FOR THE INITIAL REPORT: THIS MEDWATCH REPORT IS NOT FOR ¿PATIENT #1¿ ¿ THIS REPORT IS BEING SUBMITTED FOR UNKNOWN NUMBER OF PATIENTS. MULTIPLE ATTEMPTS WERE MADE TO OBTAIN ADDITIONAL EVENT INFORMATION; HOWEVER, THE CUSTOMER COULD NOT PROVIDE ADDITIONAL DETAILS FOR THE REPORTED ISSUE. THERE ARE STILL NO INJURIES OR HUMAN REACTIONS REPORTED FOR THIS EVENT, AND THE EXACT NUMBER OUT OF THE THIRTEEN PATIENTS INVOLVED WITH THE AFFECTED INSTRUMENTS/LOADS FOR EVOTECH #1 IS STILL UNKNOWN. IF ADDITIONAL INFORMATION BECOMES AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED AS APPLICABLE. ASP INVESTIGATION SUMMARY: THE INVESTIGATION INCLUDED A REVIEW OF THE BATCH HISTORY RECORD, TRENDING ANALYSIS OF THE LOT NUMBER, AND SYSTEM RISK ANALYSIS (SRA). ¿TRENDING ANALYSIS OF THE LOT NUMBER WAS REVIEWED FOR THE PRIOR SIX MONTHS FROM OPEN DATE AND NO SIGNIFICANT TREND WAS OBSERVED. ¿REVIEW OF RISK DOCUMENTATION SHOWS THE RISK FOR EXPOSURE TO BIOHAZARDOUS, PATHOGENIC OR INFECTIOUS MATERIAL TO BE "LOW." PRODUCT RETURN AND SUPPLIER INVESTIGATION ARE NOT REQUIRED AS THE REPORTED ISSUE IS USE ERROR AND NOT A DEFICIENCY AGAINST THE PRODUCT. THE MOST LIKELY ASSIGNABLE CAUSE OF THIS ISSUE WAS FAILURE TO FOLLOW THE CIDEX® OPA CONCENTRATE IFU, WHICH REQUIRES THE LOT NUMBER AND EXPIRATION DATE TO BE VERIFIED AND MANUALLY ENTERED INTO THE EVOTECH ECR PRIOR TO USE. ASP WILL CONTINUE TO TRACK AND TREND THIS ISSUE. ASP COMPLAINT REF #: CMP-(B)(4).

    Additional Manufacturer Narrative · 0

    THIRTEEN PATIENTS WERE REPORTED TO HAVE PROCEDURES PERFORMED WITH THE AFFECTED INSTRUMENTS PROCESSED WITH EXPIRED CIDEX OPA CONCENTRATE BY TWO EVOTECH¿ ECRS AT THE FACILITY; HOWEVER, IT IS UNCLEAR WHICH EVOTECH¿ ECR WAS INVOLVED FOR EACH PATIENT. ADVANCED STERILIZATION PRODUCTS WILL CONTINUE TO FOLLOW-UP FOR ADDITIONAL INFORMATION REGARDING THIS EVENT. THE FACILITY WAS ADVISED THAT AS PER THE CIDEX OPA CONCENTRATE INSTRUCTIONS FOR USE (IFU), THE INPUT OF THE LOT NUMBER AND THE EXPIRATION DATE MUST BE MANUALLY ENTERED INTO THE EVOTECH¿ ECR. THE CUSTOMER REPORTED THAT THE FACILITY UNIT HAD BEEN RE-TRAINED. THE BATCH RECORD REVIEW WAS PERFORMED AND NO ISSUES RELATING TO THE FAILURE MODE WERE NOTED. THE INVOLVED BATCH MET MANUFACTURER SPECIFICATIONS AT THE TIME OF RELEASE. ASP COMPLAINT REF #: (B)(4).

    Description of Event or Problem · 0

    A CUSTOMER REPORTED AN EVENT OF EXPIRED CIDEX OPA CONCENTRATE BEING USED TO REPROCESS INSTRUMENTS, WHICH WERE RELEASED FOR USE ON PATIENTS. THE EXPIRED DISINFECTANT WAS IN USE FOR APPROXIMATELY FOUR WEEKS BEFORE THE ERROR WAS DISCOVERED, AND THE AFFECTED INSTRUMENTS WERE RELEASED AND USED ON 13 PATIENTS. THERE WAS NO REPORT OF ANY INJURIES OR HUMAN REACTIONS. AS A MATTER OF POLICY, ADVANCED STERILIZATION PRODUCTS (ASP) HAS DECIDED TO REPORT ALL CASES WHERE A CUSTOMER USES EXPIRED PRODUCT AND RELEASES IT FOR USE ON PATIENTS SINCE HIGH LEVEL DISINFECTION CANNOT BE ASSURED. THE EXPIRED CIDEX OPA CONCENTRATE WAS USED IN TWO EVOTECH¿ ECRS AT THIS FACILITY. THIS REPORT IS FOR EVOTECH¿ #1 AND PATIENT #1, REFER TO THE MANUFACTURING REPORT NUMBER 2084725-2021-00435 FOR THE REPORT ON EVOTECH¿ #2 AND PATIENT #2.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1760694 CIDEX OPA CONCENTRATE BIOCIDES SOLUTIONS MED ADVANCED STERILIZATION PRODUCTS 017500\072 20705037000132

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown