BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CIDEX REGULAR

    MDR report key: 2223688 · Received August 25, 2011

    Report

    Report Number
    2084725-2011-00061
    Event Type
    Injury
    Date Received
    August 25, 2011
    Date of Event
    May 16, 2011
    Report Date
    May 17, 2011
    Manufacturer
    ADVANCED STERILIZATION PRODUCTS
    Product Code
    LRJ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    NEW INFORMATION: PATIENT AGE: (B)(6) PATIENT VITALS: BLOOD PRESSURE 109/72; TEMPERATURE 98.5; PULSE 86; (B)(6). THE HCW EXPERIENCED SYMPTOMS AFTER POURING 14 GALLONS OF CIDEX ACTIVATED DIALDEHYDE SOLUTION. IN THE MORNING. FOUR HOURS AFTER POURING THE CIDEX® ACTIVATED DIALDEHYDE SOLUTION SHE STILL SMELLED THE CHEMICAL. SHE WAS TREATED AT THE EMERGENCY DEPARTMENT ON (B)(6) 2011 FOR COMPLAINTS OF PLEURITIC CHEST PAIN AND COUGH AFTER EXPOSURE TO CIDEX ACTIVATED DIALDEHYDE SOLUTION IN THE GI LAB. SHE REPORTED THAT DURATION OF THE PAIN WAS FIVE DAYS WITH AN ASSOCIATED COUGH. HER MEDICAL HISTORY INCLUDES A SINGLE EPISODE MAJOR DEPRESSIVE DISORDER, OBESITY AND SPONDYLOARTHROPATHY. SHE IS A NON-SMOKER. AT THE TIME SHE WAS SEEN, HER CHART LISTS THE FOLLOWING OUTPATIENT MEDICATIONS ORDERED PRIOR TO HER (B)(6) 2011 EXAMINATION: AMOXICILLIN, VICODIN, MOTRIN, PENICILLIN V POTASSIUM, MELOXICAM (IS USED TO RELIEVE PAIN, TENDERNESS, SWELLING, AND STIFFNESS CAUSED BY OSTEOARTHRITIS), DOXYCYCLINE HYCLATE (A TETRACYCLINE ANTIBIOTIC), CLARITIN-D AND ALBUTEROL. IT IS UNCLEAR FROM THE RECORDS PROVIDED WHEN OR WHY THE HCW WAS PRESCRIBED THESE MEDICATIONS. THE HCW'S CHEST X-RAYS WERE NEGATIVE. THE DOCTOR'S IMPRESSION WAS THE COUGH AND PLEURITIC CHEST PAIN TREATMENT OF AN ALBUTEROL INHALER FOR SYMPTOMATIC CONTROL AND AVOIDANCE OF IRRITANT. THE HCW WAS SEEN AGAIN ON (B)(6) 2011 AND THE DOCTOR NOTED NO FORMAL RESTRICTIONS. THE HEALTHCARE WORKER RETURNED TO WORK. THE TREATING PHYSICIAN STATED THAT IF THE HCW WORKS WITH METRICIDE, "SHE SHOULD HAVE NO PROBLEMS. BUT IF WORKING WITH CIDEX ACTIVATED DIALDEHYDE SOLUTION, .I (TREATING PHYSICIAN) RECOMMEND PROPER PERSONAL PROTECTION AS PER THE MSDS." ON (B)(6) 2011 THE HCW REPORTED TO THE DOCTOR THAT THEY ARE CHANGING THE CIDEX ACTIVATED DIALDEHYDE SOLUTION FROM THE MACHINES EVERY 2 DAYS BECAUSE OF HIGH PATIENT VOLUME. SHE FEELS THERE IS NOT GOOD AIR FLOW OR VENTILATION. THE HCW REPORTS THAT HER DEPARTMENT SWITCHED BACK TO METRICIDE AND WILL STOP USING CIDEX ACTIVATED DIALDEHYDE SOLUTION.

    Additional Manufacturer Narrative · 1

    NI

    Additional Manufacturer Narrative · 1

    ASP INVESTIGATION SUMMARY: THE INVESTIGATION INCLUDED A REVIEW OF THE COMPLAINT HISTORY TRENDING, ACCOUNT HISTORY TRENDING, PRODUCT LINE TRENDING, BATCH RECORD REVIEW, FAILURE MODE EFFECTS ANALYSIS, SYSTEM HAZARD USE AND MISUSE ANALYSIS AND THE HEALTH HAZARD EVALUATION. COMPLAINT HISTORY TRENDING BY PROBLEM CODE FOR HR-OTHER AND PRODUCT, CIDEX ACTIVATED DIALDEHYDE SOLUTION FROM (B)(4) 2010 THROUGH (B)(4) 2011 REVEALED 9 COMPLAINTS IN A 12 MONTH PERIOD, WHICH AVERAGES TO LESS THAN ONE COMPLAINT PER MONTH, THEREFORE, NOT CONSIDERED A SIGNIFICANT TREND. ACCOUNT HISTORY TRENDING FOR THE PAST SIX MONTHS ((B)(4) 2011) DID NOT REVEAL ANY SIGNIFICANT TREND. THE TRENDING FOR PRODUCT BY PROBLEM CODES INDICATES NO SIGNIFICANT TREND WAS OBSERVED. A BATCH RECORD REVIEW OF THE CIDEX ACTIVATED DIALDEHYDE SOLUTION WAS PERFORMED ON TWO KNOWN LOT NUMBERS USED BY THE CUSTOMER WHICH INDICATED THAT THE PRODUCT MET ALL SPECIFICATION PRIOR TO PRODUCT RELEASE. THE FMEA (FAILURE MODE EFFECTS ANALYSIS) FOR CIDEX ACTIVATED DIALDEHYDE SOLUTION FOR SIMILAR USER SYMPTOMS INDICATED A RISK SCORE (RPN) BELOW THE THRESHOLD OF 100. THE SHUMA HAZARD HAS BEEN ASSESSED AS LOW AS REASONABLY PRACTICABLE. THE HHE (HEALTH HAZARD EVALUATION) WAS REVIEWED FOR SIMILAR ISSUES. IT INDICATES THE HAZARD/RISK IS NONE/NEGLIGIBLE. THERE WAS NO PRODUCT RETURNED FOR INVESTIGATION. TEST RESULTS OF THE RETAIN SAMPLES SHOWED EACH LOT MET PRODUCT SPECIFICATION FOR CONCENTRATION, PH, AND FUNCTIONALITY. THE TEST RESULT FROM THE RETAIN SAMPLE VERIFIES THAT THE EACH LOT STILL MEETS EFFICACY CRITERIA. THE RETAIN SAMPLE IS NOT MEANT TO REPLICATE THE CUSTOMER'S USE OR CONDITION.

    Description of Event or Problem · 1

    A HEALTHCARE WORKER REPORTED SYMPTOMS OF IRRITATION AND CHEST PAIN. THE HEALTHCARE WORKER ALLEGES THE CONDITION IS RELATED TO EXPOSURE TO CIDEX ACTIVATED DIALDEHYDE SOLUTION. THE HEALTHCARE WORKER REPORTED THE SYMPTOMS TO HER EMPLOYER ON (B)(6) 2011 AND VISITED THE DOCTOR ON THE SAME DAY. FURTHER INFORMATION FOR SPECIFIC SYMPTOMS AND/OR TREATMENT IS UNKNOWN AT THIS TIME. THE FACILITY ALLEGES THEY REPLACE THE CIDEX ACTIVATED DIALDEHYDE SOLUTION APPROXIMATELY EVERY TWO DAYS AND THE CUSTOMER ALSO STATES THEY ARE HAVING A SIMILAR PROBLEM WITH THE MATRICIDE PRODUCT USED AT THE FACILITY. THEY ARE USING THE CORRECT TEST STRIPS AND THEY DO THE "QC" UPON OPENING A NEW BOTTLE OF TEST STRIPS. THE CUSTOM ULTRASONIC UNIT (AER USED WITH THE CIDEX ACTIVATED DIALDEHYDE SOLUTION) IS REPORTED TO BE SERVICED REGULARLY.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 33 YR