BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DISOPA SOLUTION

    MDR report key: 1445110 · Received August 20, 2009

    Report

    Report Number
    2084725-2009-00496
    Event Type
    Injury
    Date Received
    August 20, 2009
    Date of Event
    June 1, 2009
    Report Date
    August 6, 2009
    Manufacturer
    ADVANCED STERILIZATION PRODUCTS
    Product Code
    MED
    PMA / PMN Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ASP INVESTIGATION SUMMARY: THE INVESTIGATION INCLUDED THE FAILURE MODE AND EFFECTS ANALYSIS, THE SYSTEM AND USER MISUSE ANALYSIS AND THE HEALTH HAZARD EVALUATION. NO LOT # WAS PROVIDED; THEREFORE, A BATCH RECORD REVIEW COULD NOT BE PERFORMED. NO LOT # WAS PROVIDED; THEREFORE, A COMPLAINT LOT HISTORY REVIEW COULD NOT BE PERFORMED. A REVIEW OF THE COMPLAINT HISTORY FROM (B)(4) 2009 THROUGH (B)(4) 2010 FIR CIDEX OPA SOLUTION (WHICH INCLUDES DISOPA SOLUTION) WITH THE PROBLEM CODE OF "HR- HEADACHE" REVEALED A DECREASING TREND. THE CIDEX OPA FMEA (FAILURE MODE AND EFFECTS ANALYSIS) AND SHUMA (SYSTEM HAZARD AND USER MISUSE ANALYSIS) WERE REVIEWED. THE FMEA SCORE FOR USER HEADACHES IS BELOW THE THRESHOLD OF (B)(4). THE HAZARD IDENTIFIED IN THE SHUMA HAS BEEN ASSESSED A (B)(4) BROADLY ACCEPTABLE RISK. THE HHE (HEALTH HAZARD EVALUATION) FOR SIMILAR ISSUES INDICATED THAT THE OCCURRENCES OF THESE COMPLAINTS ARE RELATIVELY LOW AND THE HHW INDEX IS (B)(4). THE DISOPA SOLUTION IS MANUFACTURED AND SOLD EXCLUSIVELY IN (B)(6). THE DISOPA IS SIMILAR TO CIDEX OPA SOLUTION SOLD IN THE UNITED STATES. AS INDICATED IN THE CIDEX OPA IFU (INSTRUCTIONS FOR USE), EXPOSURE TO CIDEX OPA MAY ELICIT AN ALLERGIC REACTION. POSSIBLE ALLERGIC REACTIONS HAVE BEEN REPORTED IN RARE INSTANCES. IN THE MAJORITY OF THESE INSTANCES, THE HCWS (HEALTH CARE WORKERS) WERE NOT USING THE PRODUCT IN A WELL VENTILATED ROOM OR WERE NOT WEARING PROPER PPE (PERSONAL PROTECTIVE EQUIPMENT.) IT ALSO APPEARS THAT IN SOME INSTANCES, THE HEALTHCARE WORKERS WERE NOT USING THE PRODUCT IN A MANNER CONSISTENT WITH THE IFU. EXPOSURE TO (B)(4) VAPORS MAY BE IRRITATING TO THE RESPIRATORY TRACT AND EYES. IT MAY CAUSE STINGING SENSATION IN THE NOSE AND THROAT, DISCHARGE, COUGHING, CHEST DISCOMFORT AND TIGHTNESS, DIFFICULTY WITH BREATHING, WHEEZING, TIGHTENING OF THROAT, URTICARIA (HIVES), RASH, LOSS OF SMELL, TINGLING OF MOUTH OR LIPS, DRY MOUTH OR HEADACHE. VAPORS MAY AGGRAVATE PREEXISTING ASTHMA OR BRONCHITIS. SYMPTOMS ARE TYPICALLY TRANSIENT AND DISAPPEAR ONCE THE USER IS MOVED TO A WELL-VENTILATED AREA. THE CIDEX OPA INSTRUCTIONS FOR USE STATES TO USE CIDEX OPA SOLUTION IN A WELL-VENTILATED AREA AND IN CLOSED CONTAINERS WITH TIGHT-FITTING LIDS. IF ADEQUATE VENTILATION IS NOT PROVIDED BY THE EXISTING AIR CONDITIONING SYSTEM, USE IN LOCAL EXHAUST HOODS, OR IN DUCTLESS FUME HOODS/PORTABLE VENTILATION DEVICES WHICH CONTAIN FILTER MEDIA THAT ABSORB (B)(4) FROM THE AIR. THE ENDOSCOPY ROOM WAS DESCRIBED AS HAVING A VENTILATING FAN AND THAT THE VENTILATION WAS "NOT TOO POOR" AND THE ONLY PPE (PERSONAL PROTECTIVE EQUIPMENT) WORN BY THE HCW (HEALTHCARE WORKER) IS AN APRON. A CAPA (CORRECTIVE AND PREVENTIVE ACTION PLAN) WAS OPENED TO INVESTIGATE HEALTHCARE WORKER REPORTS OF HUMAN REACTION SYMPTOMS WHILE WORKING WITH CIDEX OPA SOLUTION. THROUGH THE INVESTIGATION, IT WAS DETERMINED THAT INADEQUATE VENTILATION AND/OR POSSIBLY USER RELATED ISSUES WERE CONTRIBUTING TO THE MAJORITY OF THESE REPORTED HUMAN REACTIONS SYMPTOMS. SOME POTENTIAL CAUSES OF HCW REPORTED SYMPTOMS INCLUDE INADEQUATE VENTILATION OF THE ROOM, IMPROPER USE OF THE SOLUTION AND/OR INADEQUATE USE OF PPE.

    Additional Manufacturer Narrative · 1

    SORE THROAT - INHALATION. REFERENCES: 2084725-2009-00492, 084725-2009-00495.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A HEALTHCARE WORKER (HCW) IN AN ENDOSCOPY ROOM EXPERIENCED HEADACHE AND SORE THROAT. THE WORKER DID NOT SEE DOCTOR AND DID NOT NEED ANY TREATMENT. THE LOT OF THE DISOPA USED IS UNK AND NO SAMPLE IS AVAILABLE FOR EVAL. THE SYMPTOMS WERE REPORTED A FEW DAYS AFTER USE OF DISOPA. IT WAS SUBSEQUENTLY REPORTED THAT THE HCW RECOVERED. THE FACILITY WAS USING OER2 WITH UNK DISINFECTANT AND ENZYMATIC DETERGENT AND THEN CONVERTED INTO ENDOCLENS WITH DISOPA AND MILDLY ALKALINE DETERGENT. THE PROCESSING ROOM HAS A VENTILATING FAN. THE VENTILATION OF THE ROOM WAS DESCRIBED AS INADEQUATE, BUT "NOT SO VERY POOR." NO FURTHER INFO IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DISOPA SOLUTION BIOCIDES SOLUTIONS MED ADVANCED STERILIZATION PRODUCTS NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK ENDOCLENS