BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CIDEX ACTIVATED DIALDEHYDE SOLUTION

    MDR report key: 1580028 · Received January 13, 2010

    Report

    Report Number
    2084725-2009-00721
    Event Type
    Injury
    Date Received
    January 13, 2010
    Date of Event
    October 1, 2009
    Report Date
    December 15, 2009
    Manufacturer
    ADVANCED STERILIZATION PRODUCTS
    Product Code
    LRJ
    PMA / PMN Number
    K924434
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ASP INVESTIGATION SUMMARY: THE INVESTIGATION INCLUDED COMPLAINT TRENDING BY PROBLEM CODES, FAILURE MODE AND EFFECTS ANALYSIS, AND HEALTH HAZARD EVALUATION. NO LOT NUMBER WAS PROVIDED FOR THIS COMPLAINT AND NO SAMPLES WERE RETURNED FOR EVALUATION. A REVIEW OF THE COMPLAINTS FROM (B)(4) 2009 THROUGH (B)(4) 2010 FOR CIDEX ACTIVATED DIALDEHYDE SOLUTION WITH THE PROBLEM CODE "HRU-RESPIRATORY REACTION" DID NOT REVEAL ANY OTHER COMPLAINTS; THEREFORE, IT IS NOT CONSIDERED A SIGNIFICANT TREND. THE CIDEX FMEA (FAILURE MODE AND EFFECTS ANALYSIS) WAS REVIEWED FOR POTENTIAL RESPIRATORY SYMPTOMS TO USERS. THE RPN (RISK PRIORITY NUMBER) WAS FOUND TO BE BELOW THE THRESHOLD OF (B)(4). THE HHE (HEALTH HAZARD EVALUATION) FOR SIMILAR SYMPTOMS WITH USE OF CIDEX INDICATED A HAZARD/RISK INDEX OF (B)(4) OR NONE/NEGLIGIBLE. FOLLOW UP INFORMATION INDICATED THE HCW (HEALTHCARE WORKER) WAS PRESCRIBED FLOVENT AND BUTEROL AND WAS REPORTED TO BE GETTING BETTER. IT WAS SUBSEQUENTLY REPORTED THAT THE HCW NO LONGER WORKS WITH CIDEX. IT WAS NOT KNOWN IF THE ROOM WAS WELL VENTILATED AND THE AIR EXCHANGES WERE NOT MEASURED. THE ASP CLINICAL SUPPORT REPRESENTATIVE REVIEWED AND SENT THE CIDEX SOLUTION IFU (INSTRUCTIONS FOR USE) TO THE CUSTOMER. CIDEX ACTIVATED DIALDEHYDE SOLUTION MAY CAUSE SENSITIZATION BY INHALATION. VAPOR IS IRRITATING TO THE RESPIRATORY TRACT, CAUSING STINGING SENSATIONS IN THE NOSE AND THROAT. MAY CAUSE BLEEDING FROM THE NOSE, COUGHING, CHEST DISCOMFORT AND TIGHTNESS, DIFFICULTY WITH BREATHING AND HEADACHE. INHALATION OF VAPOR MAY CAUSE ASTHMA-LIKE SYMPTOMS (CHEST DISCOMFORT AND TIGHTNESS, DIFFICULTY WITH BREATHING). GLUTARALDEHYDE HAS BEEN REPORTED TO CAUSE OCCUPATIONAL ASTHMA AND MAY AGGRAVATE EXISTING ASTHMA AND INFLAMMATORY OR FIBROTIC PULMONARY DISEASE. THE INSTRUCTIONS FOR USE (IFU) INDICATE TO USE CIDEX SOLUTION IN A WELL-VENTILATED AREA IN CLOSED CONTAINERS WITH TIGHT FITTING LIDS. USE IN LOCAL EXHAUST HOODS OR IN DUCTLESS FUME HOODS/PORTABLE VENTILATION EQUIPMENT, WHICH CONTAIN FILTER MEDIA THAT ABSORB GLUTARALDEHYDE FROM THE AIR, IF ADEQUATE VENTILATION IS NOT PROVIDED BY THE EXISTING AIR CONDITIONING SYSTEM.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT A HEALTHCARE WORKER (HCW) DEVELOPED PNEUMONIA-LIKE SYMPTOMS THAT LASTED ABOUT 2 MONTHS. THE HCW SAW A PHYSICIAN WHO STATED THAT THE HCW'S LUNGS WERE CLEAR AND THAT SHE HAS A SENSIVITIVITY TO GLUTARALDEHYDE. THE HCW HAS WORKED WITH GLUTARALDEHYDE FOR ABOUT 15 YEARS AND THIS IS THE FIRST TIME THAT SHE HAS HAD REACTIONS WORKING WITH THE PRODUCT. THE FACILITY USES CIDEX IN A MANUAL SOAK TRAY. THE AIR EXCHANGES HAVE NOT BEEN MEASURED IN THE FACILITY. IT WAS REPORTED THAT THE HCW WORE GOGGLES, GOWN AND GLOVES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CIDEX ACTIVATED DIALDEHYDE SOLUTION BIOCIDES SOLUTIONS (LRJ) LRJ ADVANCED STERILIZATION PRODUCTS NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 40 YR