BEUDAMED
    FDA Adverse Event Death Summary report: N

    CIDEX OPA SOLUTION

    MDR report key: 5906765 · Received August 26, 2016

    Report

    Report Number
    2084725-2016-00491
    Event Type
    Death
    Date Received
    August 26, 2016
    Date of Event
    April 1, 2016
    Report Date
    August 1, 2016
    Manufacturer
    ADVANCED STERILIZATION PRODUCTS
    Product Code
    MED
    PMA / PMN Number
    K991487
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PER ASP EDUCATION RECORDS, THIS HCW WAS TRAINED, AND SIGNED AND ACKNOWLEDGED THE EVOTECH COMPETENCY CHECKLIST WHICH INCLUDED THE FOLLOWING: FOLLOW SOCIETY OF GASTROENTEROLOGY NURSES PRE-CLEANING GUIDELINES. VERBALIZE THE PROCESS TO CHANGE THE CIDEZYME XTRA SOLUTION. LOCATE AND DISCUSS THE FUNCTION AND IMPORTANCE OF USER¿S GUIDE. PER A HOSPITAL REPRESENTATIVE, ADDITIONAL INTERNAL TRAINING WAS COMPLETED FOR ALL EMPLOYEES WHO WORK IN THE ER ROOM, INCLUDING THIS HCW. IT WAS ALSO REPORTED BY THE HOSPITAL REPRESENTATIVE, THEY CHANGED THEIR SOAKING SOLUTION IN (B)(6) 2016 FROM METRICIDE GLUTARALDEHYDE (GTA) TO METRICIDE OPA PLUS. BOTH OF THESE SOLUTIONS ARE NON-ASP PRODUCTS. A HOSPITAL REPRESENTATIVE REPORTED THIS HCW ACKNOWLEDGED THE CIDEZYME XTRA LABEL. THIS ASP PRODUCT CLEARLY STATES ¿SUSPECTED OF DAMAGING FERTILITY OR THE UNBORN CHILD¿; HOWEVER, THIS HCW DID NOT REPORT DIRECT CORRELATION OF THE MISCARRIAGE AND USE OF CIDEZYME XTRA. IT IS UNKNOWN HOW FREQUENTLY THIS HCW WAS EXPOSED DIRECTLY OR INDIRECTLY TO CIDEZYME XTRA, AS WELL AS THE OTHER NON-ASP CHEMICALS IN THE ER ROOM. IT IS UNKNOWN IF THIS HCW WORE PERSONAL PROTECTIVE EQUIPMENT PER CIDEZYME XTRA INSTRUCTIONS FOR USE OR LABEL, OR ANY OTHER NON-ASP CHEMICALS IN THE ER ROOM. FURTHERMORE, THIS HCW CONTINUES TO WORK IN THE ER ROOM AROUND THE EVOTECH UNITS, OTHER NON-ASP CHEMICALS, AND CIDEZYME XTRA, REGARDLESS OF HER KNOWLEDGE OF THE LABEL. REGARDING THIS HCW, HER PAST MEDICAL HISTORY IS UNKNOWN. BASED ON THE INFORMATION CONTAINED IN THE COMPLAINT AT THE TIME THE REPORTING DETERMINATION WAS MADE, THIS COMPLAINT IS DEEMED REPORTABLE. A DECISION WAS MADE TO FILE A FDA MEDWATCH REPORT, DUE TO THE FACT THAT THE CUSTOMER REPORTED USING CIDEZYME XTRA; HOWEVER, THE HCW DID NOT REPORT A DIRECT CORRELATION BETWEEN MISCARRIAGE AND THE USE OF CIDEZYME XTRA. THIS EVENT IS BEING REPORTED AS A FETAL DEATH, AS THE STATE OF ILLINOIS REQUIRES A REPORT TO BE FILED FOR EACH FETAL DEATH WHICH OCCURS IN THE STATE AFTER A GESTATION PERIOD OF 20 COMPLETED WEEKS OR MORE. IN THIS EVENT, A HOSPITAL REPRESENTATIVE REPORTED THE HCW MISCARRIED AT FIVE MONTHS. CORRECTED DATA: BRAND NAME - THE CORRECT BRAND NAME IS CIDEZYME XTRA DETERGENT, CATALOG NUMBER - THE CORRECT CATALOG NUMBER IS 22591.

    Additional Manufacturer Narrative · 1

    CORRECTED DATA: THE INITIAL MDR STATED THE FOLLOWING: THE HEALTHCARE WORKER DID NOT REPORT A DIRECT CORRELATION OF THE MISCARRIAGE AND USE OF CIDEZYME XTRA. THIS STATEMENT WAS MADE IN ERROR AND SHOULD BE REMOVED. ASP INVESTIGATION SUMMARY: THE INVESTIGATION INCLUDED A REVIEW OF THE BATCH HISTORY RECORD, COMPLAINT TRENDING, SYSTEM RISK ANALYSIS(SRA), VISUAL ANALYSIS, SUPPLIER PRODUCT EVALUATION AND RETAINS ANALYSIS. THE BATCH HISTORY RECORD COULD NOT BE REVIEWED AS THE LOT NUMBER WAS NOT AVAILABLE. COMPLAINT TRENDING COULD NOT BE PERFORMED AS THE LOT NUMBER WAS NOT AVAILABLE. THE SRA INDICATES THE RISK ASSOCIATED WITH EXPOSURE TO TOXIC OR CORROSIVE MATERIAL WAS DETERMINED TO BE A "MEDIUM" RISK. VISUAL ANALYSIS WAS NOT PERFORMED AS THE PRODUCT WAS NOT AVAILABLE FOR RETURN. THE SUPPLIER WAS NOT NOTIFIED OF THE ISSUE AS THE ISSUE WAS NOT IDENTIFIED AS A MANUFACTURING OR FUNCTIONAL ISSUE. RETAINS TESTING WAS NOT PERFORMED AS THE ISSUE WAS NOT IDENTIFIED AS A MANUFACTURING OR FUNCTIONAL ISSUE. THE SUPPLIER WAS NOT NOTIFIED AS THE ISSUE WAS NOT IDENTIFIED AS A MANUFACTURING OR FUNCTIONAL ISSUE. THE ASSIGNABLE CAUSE COULD NOT BE DETERMINED AT THIS TIME AS THERE WERE MANY NON-ASP CHEMICALS THAT ARE ALSO USED IN THE PROCESSING ROOM, BOTH EVOTECH ECR'S WERE TESTED AND DETERMINED TO BE OPERATING WITHIN SPECIFICATIONS, AND AIR EXCHANGES WERE DETERMINED TO BE WITHIN NORMAL LIMITS IN THE PROCESSING ROOM. THE ISSUE WILL CONTINUE TO BE TRACKED AND TRENDED.

    Additional Manufacturer Narrative · 1

    IT WAS ORIGINALLY REPORTED BY A CUSTOMER, THERE WAS ODOR COMING FROM THREE EVOTECH UNITS IN THE ENDOSCOPIC REPROCESSING ROOM, AND A HEALTH CARE WORKER (HCW) HAD A MISCARRIAGE AT FIVE MONTHS WITH ANENCEPHALY. A HEALTH RISK ASSESSMENT (HRA) WAS COMPLETED BY ASP MEDICAL SAFETY OFFICER (MSO) AND CONCLUDED THE FOLLOWING: ALL EVOTECH UNITS WERE FOUND TO BE OPERATING TO SPECIFICATION, NO LEAKS WERE DETECTED, AND NO ODORS WERE NOTED. THE ASP FIELD SERVICE ENGINEER REPORTED THERE WERE OTHER CHEMICALS BEING USED IN THE REPROCESSING ROOM THAT WERE NON-ASP PRODUCTS. THE FACILITY¿S VICE PRESIDENT OF NURSING SPECIFICALLY MENTIONED THE CIDEZYME XTRA SAFETY DATA SHEET (SDS) REPRODUCTIVE TOXICITY LABELING; HOWEVER, THERE WAS NO ALLEGATION OF HARM. CIDEZYME XTRA MULTI-ENZYMATIC DETERGENT IS A LIQUID CONCENTRATE FORMULA DEVELOPED BY THE CONTRACT MANUFACTURER, WEIMAN PRODUCTS, LLC. WHEN USED AS DIRECTED, IT IS A LOW-FOAMING, MILD PH CLEANING SOLUTION WHICH COMBINES CHEMICAL AND MULTI-ENZYMATIC ACTIONS TO RAPIDLY REMOVE MEDICAL SOILS (E.G. BLOOD). THE PRODUCT ALSO CONTAINS CORROSION INHIBITORS TO ENSURE COMPATIBILITY WITH MEDICAL DEVICES. THE ENZYMATIC DETERGENT IS SPECIALLY FORMULATED AND CAN BE USED WITH EVOTECH UNITS. ONE OF THE MAIN INGREDIENTS IN CIDEXZYME XTRA IS A BUFFER STABILIZER (DISODIUM TETRABORATE DECAHYDRATE/ANHYDROUS OR COMMON NAME BORAX). BORAX CONCENTRATION IN ASP PRODUCT FORMULATION IS 3-7%. BORAX CONCENTRATION IN DILUTED IN-USE SOLUTION (AS RECOMMENDED FOR USE IN EVOTECH) IS 0.028%. BORAX CONCENTRATIONS ARE USED TO EVALUATE LABELING REQUIREMENTS. THIS REQUIREMENT DOES NOT TAKE INTO CONSIDERATION THE TYPE OF BORAX EXPOSURE (INGESTION VS. SKIN EXPOSURE). PER USA REGULATIONS: OSHA HAZCOM CLASSIFIES A MIXTURE AS A REPRODUCTIVE TOXICANT IF THE CONCENTRATION OF A CLASSIFIED REPRODUCTIVE TOXICANT INGREDIENT IS = 0.1%. EXCEEDING THE CONCENTRATION OF = 0.1% REQUIRES THE REPRODUCTIVE TOXICITY CATEGORY 2 LANGUAGE TO BE PLACED ON THE LABEL, ¿SUSPECTED OF DAMAGING FERTILITY OR THE UNBORN CHILD.¿ ASP¿S MANUFACTURER (WEIMAN PRODUCTS, LLC) PROVIDED CIDEZYME XTRA CLASSIFICATION OF REPRODUCTIVE TOXICITY CATEGORY 2 TO THE ASP GENERATED SDS. A LITERATURE SEARCH WAS COMPLETED AND OVER 35 LITERATURE CITATIONS REGARDING BORAX WERE REVIEWED AND FOUND: THE REPORTED REPRODUCTIVE TOXICITY HAZARD ASSOCIATED WITH BORAX IS BY INGESTION EXPOSURE. TAKING INTO CONSIDERATION THIS ROUTE OF BORAX EXPOSURE, IT IS NOT REASONABLE TO EXPECT THERE IS A RISK FOR REPRODUCTIVE TOXICITY IN ANY OF ASP CUSTOMER POPULATIONS. IT IS NOT REASONABLE TO EXPECT A CUSTOMER WOULD INGEST CIDEZYME XTRA. SKIN CONTACT HAZARDS WERE REPORTED (1983 BEYER) IN INFANT AND INJURED SKIN. IT IS NOT REASONABLE TO EXPECT A CUSTOMER WOULD HAVE AN EXPOSURE TO BORAX WITH THE PROPER PERSONAL PROTECTIVE EQUIPMENT REQUIRED FOR USE OF CIDEZYME XTRA. REGARDING THIS COMPLAINT, THE MSO NOTED THE FOLLOWING: THE EXACT CAUSE OF THE ANENCEPHALY WILL NEVER BE KNOWN. IT IS UNLIKELY TO BE CAUSED BY CIDEZYME XTRA BECAUSE THE HCW DID NOT INGEST IT. THE CAUSE FOR THE ANENCEPHALY IS MOST LIKELY DUE TO A GENETIC MUTATION AND/OR A MATERNAL FOLATE DEFICIENCY DURING NEURAL TUBE DEVELOPMENT. BASED ON THE RESEARCH INFORMATION THIS COMPLAINT IS NOW DEEMED NOT REPORTABLE. THE HCW DID NOT INGEST CIDEZYME XTRA, BUT INSTEAD REPORTED AN ODOR COMING FROM THE EVOTECH UNITS IN THE ENDOSCOPIC REPROCESSING ROOM.

    Description of Event or Problem · 1

    IT WAS REPORTED BY A CUSTOMER, A HEALTHCARE WORKER (HCW) INDICATED IN THE PAST, AN ODOR WAS COMING FROM THREE EVOTECH UNITS IN THEIR ENDOSCOPIC REPROCESSING (ER) ROOM. AFTER FURTHER INVESTIGATION, IT WAS REPORTED THE HCW HAD MISCARRIAGE WITH ANENCEPHALY AFTER WORKING IN THE ER ROOM. TWO ADVANCED STERILIZATION PRODUCTS (ASP) FIELD SERVICE TECHNICIANS (FSE) VISITED THE SITE AND MET WITH THE CUSTOMER AND FACILITIES DEPARTMENTS, AND INSPECTED ALL THREE EVOTECH UNITS IN THE ER ROOM. THEY REPORTED ALL UNITS WERE OPERATING TO SPECIFICATION AND NO LEAKS WERE DETECTED, AND NO ODORS WERE NOTED. IN ADDITION, THE FSE REPORTED THERE WERE OTHER CHEMICALS BEING USED IN THIS ER ROOM THAT WERE NON-ASP PRODUCTS. THE ASP CLINICAL EDUCATION CONSULTANT (CEC) CONFIRMED THERE WERE OTHER NON-ASP CHEMICALS BEING USED IN THIS ER ROOM TO PROCESS AND CLEAN THE ENDOSCOPES AND OTHER INSTRUMENTS. PER THE HOSPITAL REPRESENTATIVE, THE ER ROOM WAS WELL VENTILATED, AND AIR EXCHANGES WERE MEASURED 13-15 PER HOUR, WHICH ARE WITHIN NORMAL LIMITS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    559922 CIDEX OPA SOLUTION BIOCIDES SOLUTIONS (MED) MED ADVANCED STERILIZATION PRODUCTS NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Death