BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DISOPA SOLUTION

    MDR report key: 1580026 · Received January 13, 2010

    Report

    Report Number
    2084725-2010-00008
    Event Type
    Injury
    Date Received
    January 13, 2010
    Date of Event
    December 1, 2003
    Report Date
    December 16, 2009
    Manufacturer
    ADVANCED STERILIZATION PRODUCTS
    Product Code
    LRJ
    PMA / PMN Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    REFERENCES: 2084725-2009-00691. SUPPLEMENTAL 1. REPORTS: 2084725-2010-00010 INITIAL; 2084725-2010-00011 INITIAL; 2084725-2010-00013 INITIAL; 2084725-2010-00014 INITIAL; 2084725-2010-00015 INITIAL.

    Additional Manufacturer Narrative · 1

    ASP INVESTIGATION SUMMARY: THE INVESTIGATION INCLUDED COMPLAINT TRENDING BY PROBLEM CODE, FAILURE MODE AND EFFECTS ANALYSIS, SYSTEM HAZARD AND USER MISUSE ANALYSIS, AND HEALTH HAZARD EVALUATION. THE DISOPA SOLUTION LOT NUMBER WAS NOT AVAILABLE TO PERFORM A BATCH RECORD REVIEW. A REVIEW OF THE DPMO (DEFECTS PER MILLION OPPORTUNITIES) OVER THE PAST 12 MONTHS (NOVEMBER 2009 TO OCTOBER 2010) FOR CIDEX OPA SOLUTION (WHICH INCLUDES DISOPA SOLUTION) WITH THE PROBLEM CODE OF "HR-ALLERGIC SYMPTOMS" AND "HRU-RESPIRATORY REACTION" WAS REVIEWED. THE OVERALL TREND HAS BEEN BELOW THE UCL (UPPER CONTROL LIMIT). THE CIDEX OPA FMEA (FAILURE MODE AND EFFECTS ANALYSIS) AND SHUMA (SYSTEM HAZARD AND USER MISUSE ANALYSIS) WERE REVIEWED. THE FMEA SCORE FOR USER RESPIRATORY REACTION IS BELOW THE THRESHOLD OF 100, AND THE HAZARD IDENTIFIED IN THE SHUMA HAS BEEN ASSESSED A CATEGORY I - BROADLY ACCEPTABLE RISK. THE HHE (HEALTH HAZARD EVALUATION) FOR SIMILAR SYMPTOMS WHICH INDICATED THE ASSOCIATED RISK IS NONE/NEGLIGIBLE. THE REPORT RECEIVED FROM THE AFFILIATE INDICATES THIS FACILITY BEGAN TO USE DISOPA IN 2004. THE ALLEGED REACTION OCCURRED ON (B)(6) 2003, ADDITIONAL REQUEST FOR CLARIFICATION OF THE EVENT DATE WAS MADE, HOWEVER, THE FACILITY HAS DECLINED TO PROVIDE ADDITIONAL INFORMATION. IT IS UNKNOWN IF THE AIR EXCHANGE FOR THE ROOM WAS MEASURED. THE AFFILIATE INDICATED THAT THE DISINFECTION ROOM WAS NOT WELL VENTILATED AND THAT EACH DEPARTMENT WITHIN THE FACILITY USES DISOPA IN THEIR OWN WAY. THE AFFILIATE STATES THE FACILITY NEEDED TRAINING FOR EACH DEPARTMENT AND THAT THE SALES REPRESENTATIVE WAS FACILITATING THE TRAINING. HOWEVER, THE OTOLOGY DEPARTMENT IN THE HOSPITAL CHANGED THE SCOPE REPROCESSOR AND STOPPED USING DISOPA AS OF AUGUST 2010. NO FURTHER INFORMATION WAS PROVIDED. THE DISOPA SPECIFIC LOT NUMBER WAS NOT PROVIDED. NO PRODUCT WAS RETURNED FOR EVALUATION. INFORMATION RECEIVED FROM THE AFFILIATE INDICATES THE FACILITY HAS DECLINED TO PROVIDE ADDITIONAL INFORMATION REGARDING THIS COMPLAINT. DISOPA SOLUTION IS MANUFACTURED IN (B)(4) AND SOLD EXCLUSIVELY IN (B)(4). 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 HEALTH CARE WORKERS WERE NOT USING THE PRODUCT IN A WELL-VENTILATED ROOM OR NOT WEARING PROPER PPE (PERSONAL PROTECTIVE EQUIPMENT). EXPOSURE TO ORTHO-PHTHALALDEHYDE 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. A CAPA (CORRECTION AND PREVENTIVE ACTION PLAN) WAS OPENED TO INVESTIGATE HCW 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 REACTION SYMPTOMS. THE INFORMATION SUGGESTS THAT INADEQUATE PPE (PERSONAL PROTECTIVE EQUIPMENT) AND USER ERROR CONTRIBUTED TO THE REPORTED EVENT. DUE TO THE LOW HEALTH/RISK INDEX, NO FURTHER ACTION IS REQUIRED.

    Description of Event or Problem · 1

    IT IS ALLEGED THAT DISOPA WAS RELATED TO REPORTS OF VARIOUS SYMPTOMS EXPERIENCED BY ELEVEN HEALTHCARE WORKERS (HCW) BUT SPECIFIC INFORMATION WAS ONLY RECEIVED FOR SEVEN HCWS. THIS IS THE REPORT FOR THE SECOND HCW WHO EXPERIENCED ASTHMA. WHEN SHE IS NOT NEAR DISOPA, SHE HAS NO REACTION BUT SHE EXPERIENCES AN (ASTHMA) ATTACK WHEN SHE IS FEELING SICK. SHE WENT TO SEE A RESPIRATORY PHYSICIAN BUT NO INFORMATION REGARDING MEDICAL TREATMENT WAS PROVIDED. THE FACILITY ONLY HAD AIR-CONDITIONING EQUIPMENT AND THERE WAS NO VENTILATING FAN. THE WINDOW COULD NOT BE OPENED, SO A PORTABLE AIR CLEANING DEVICE WAS BROUGHT INTO THE ROOM. SHE WORE AN APRON, A MASK, AND GLOVES WHEN WORKING WITH THE PRODUCT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 35 YR