BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DISOPA SOLUTION

    MDR report key: 2152020 · Received July 7, 2011

    Report

    Report Number
    2084725-2011-00046
    Event Type
    Injury
    Date Received
    July 7, 2011
    Date of Event
    June 8, 2011
    Report Date
    June 8, 2011
    Manufacturer
    ADVANCED STERILIZATION PRODUCTS
    Product Code
    MED
    PMA / PMN Number
    K991487
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ASP INVESTIGATION SUMMARY: THE INVESTIGATION INCLUDED A REVIEW OF THE COMPLAINT HISTORY TRENDING, BATCH RECORD REVIEW, FAILURE MODE EFFECTS ANALYSIS, SYSTEM HAZARD USE MISUSE ANALYSIS AND HEALTH HAZARD ANALYSIS. COMPLAINT HISTORY TRENDING FOR DISOPA SOLUTION FOR THE PROBLEM RELATED TO RESPIRATORY REACTION AND ALLERGIC SYMPTOMS DID NOT REVEAL A SIGNIFICANT TREND. BATCH RECORD REVIEW OF DISOPA SOLUTION WAS NOT POSSIBLE SINCE THE LOT NUMBER WAS UNKNOWN. (B)(4). THERE WAS NO PRODUCT RETURNED FOR INVESTIGATION. THE LOT NUMBER WAS NOT AVAILABLE FOR RETAIN EVALUATION. THE DISOPA SOLUTION IS MANUFACTURED IN (B)(4) AND SOLD EXCLUSIVELY IN (B)(6). DISOPA IS SIMILAR TO CIDEX OPA SOLUTION SOLD IN THE UNITED STATES. AS INDICATED IN THE CIDEX OPA SOLUTION INSTRUCTIONS FOR USE (IFU), EXPOSURE TO CIDEX OPA SOLUTION (SAME AS DISOPA SOLUTION) MAY ELICIT AN ALLERGIC REACTION. AVOID EXPOSURE TO ORTHO-PHTHALALDEHYDE (OPA) VAPORS, AS THEY MAY BE IRRITATING TO THE RESPIRATORY TRACT AND EYES. DISOPA SOLUTION MAY AGGRAVATE PREEXISTING ASTHMA OR BRONCHITIS. SYMPTOMS ARE TYPICALLY TRANSIENT AND DISAPPEAR ONCE THE USER IS MOVED TO A WELL-VENTILATED AREA. 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 WHICH ABSORB OPA FROM THE AIR. USERS SHOULD BE TRAINED IN THE PROPER HANDLING OF OPA SOLUTION. IT HAS BEEN IDENTIFIED IN THE RISK DOCUMENTS THAT RESPIRATORY REACTION MAY BE CAUSED BY INADEQUATE VENTILATION, SPILLS, SPLASH, IMPROPER PPE, ODOR, LEAKAGE FROM AER, AND UNCOVERED TRAYS.

    Additional Manufacturer Narrative · 1

    IT WAS REPORTED THAT THE HCW TOOK MEDICAL LEAVE AS BELOW: FIRST MEDICAL LEAVE: FROM (B)(6) 2011 TO (B)(6) 2011. SECOND MEDICAL LEAVE: FROM (B)(6) 2011 TO (B)(6) 2011. THE DOCTOR STATED AS FOLLOWS: SYMBICORT TURBUHALER, ONON, PREDONINE AND ADVAIR DISKUS INHALER WERE TREATMENT DRUGS AND CLARITH TABLETS, PARIET, NAUZELIN TABLETS AND FORMALIN WERE CONCOMITANT DRUGS. THE FACILITY STATES THAT THIS EVENT IS RELATED TO THE HCW 'S WORKING ENVIRONMENT WHERE DISOPA AND SOME OTHER CHEMICAL WAS USED, RATHER THAN DUE TO A FAILURE OF DISOPA ITSELF. THE FACILITY WAS INFORMED ABOUT A KIND (TYPE) OF MASK WHICH CAN HIGHLY PROTECT FROM EXPOSURE. THEY HAVE STOPPED USING DISOPA WITH A TRAY (THEY CONTINUE USE OF THE DISOPA WITH ENDOCLENS). ADDITIONALLY, THE VENTILATION HAS BEEN IMPROVED. THE FACILITY IS ALSO CONSIDERING ESTABLISHING A NEW ROOM FOR WASHING AND DISINFECTING INSTRUMENTS.

    Additional Manufacturer Narrative · 1

    RELEVANT HISTORY, PREEXISTING MEDICAL CONDITIONS - CORRECTION: NKA. ADDITIONAL INFORMATION: RECEIVED TIMELINE OF REPORTED SYMPTOMS AND MEDICATION. (B)(6) 2011 - DIFFICULTY BREATHING, COUGHING, SPUTUM - UNSPECIFIED ORAL MEDICATION. (B)(6) 2011 - WHEEZING AND BRONCHIAL ASTHMA - SYMBICORT TURBUHALER AND CLARITH TAB. (B)(6) 2011 - COUGH ONGOING . (B)(6) 2011 - DIFFICULTY BREATHING, COUGHING, SPUTUM, WHEEZING - "ONON" AND PREDONINE. (B)(6) 2011 - "RINDERON" IV AND "NEOPHYLLIN" IV WAS PERFORMED - ADOAIR DISKUS INHALER (B)(6) 2011 - "RINDERON" IV WAS PERFORMED AGAIN. EXPERIENCED NAUSEA AND MUSCLE PAIN - PARIEL AND NAUZELIN TABLETS. (B)(6) 2011 - SYMPTOMS DECREASED-RETURNED TO WORK 6/14 NOT IN ENDOSCOPY DEPARTMENT - ADOAIR DISKUS INHALER. (B)(6) 2011 - SYMPTOMS ARE STABILIZED THROUGH CONTINUED TREATMENT. THE DOCTOR STATED THAT THE HCW'S EVENT MAY BE RELATED TO THE OCCUPATIONAL ENVIRONMENT AND THAT THE CAUSALITY BETWEEN THE HCW'S ASTHMA ATTACK AND THE PRESENCE OF DISOPA IS NOT NEGATED. THE HCW'S SYMPTOMS IMPROVE WHEN SHE IS NOT WORKING WITH OR NEAR DISOPA AND WORSEN WHEN THE DISOPA IN THE MACHINE GETS CHANGED.

    Description of Event or Problem · 1

    A HEALTHCARE WORKER (HCW) REPORTED ALLERGIC SYMPTOMS WHEN POURING DISOPA INTO AN AUTOMATIC ENDOSCOPE RE-PROCESSOR. THE SYMPTOMS WERE REPORTED TO BE ASTHMA-LIKE AND A COUGH. THE HEALTHCARE WORKER SOUGHT MEDICAL TREATMENT IN (B)(6) AND WAS DIAGNOSED WITH ASTHMA. THE SYMPTOMS WERE DESCRIBED AS SERIOUS AND STARTED WHEN DISOPA WAS USED BEGINNING (B)(6) 2011. THE SYMPTOMS WERE TREATED WITH A STEROID INHALER, A BRONCHODILATOR, AN ORAL STEROID, A DRIP INFUSION OF NEOPHYLLIN (AMINOPHYLLIN HYDRATE). THE HCW SYMPTOMS ARE NOW IN REMISSION. THE HEALTHCARE WORKER WAS ABSENT FROM WORK FOR ONE WEEK AND IS CURRENTLY WORKING IN THE ICU DEPARTMENT. THE HEALTHCARE WORKER WORE A SURGICAL MASK. IT WAS SUGGESTED THEM TO USE AN ACTIVE CARBON MASK. IT WAS REPORTED THAT THERE WAS A STRONG AIR FAN BEHIND EACH OF THE TWO ENDOCLENS-D AUTOMATIC ENDOSCOPE RE-PROCESSORS ((B)(4)). ENDOSCOPES ARE PROCESSED IN THE ENDOCLENS-D AND OTHER INSTRUMENTS ARE REPORTED TO BE DISINFECTED IN A TRAY WITH DISOPA. THE HCWS STATED THAT THEY WILL DISCONTINUE USING THE TRAY WITH SOLUTION. OTHER PRODUCTS IN THE ENDOSCOPE ROOM INCLUDE FORMALIN WHICH IS USED TO PRESERVE SAMPLES AND "OTHER MEDICATIONS" WHICH WERE NOT SPECIFIED. TWO AER'S (SERIAL NUMBER UNKNOWN) AT THE HOSPITAL WERE REPORTED TO BE FUNCTIONING NORMALLY WITH NO ERROR.

    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 32 YR