BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CIDEX ACTIVATED DIALDEHYDE SOLUTION

    MDR report key: 2071188 · Received April 27, 2011

    Report

    Report Number
    2084725-2011-00031
    Event Type
    Injury
    Date Received
    April 27, 2011
    Date of Event
    February 23, 2011
    Report Date
    March 30, 2011
    Manufacturer
    ADVANCED STERILIZATION PRODUCTS
    Product Code
    LRJ
    PMA / PMN Number
    K924434
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    NI

    Additional Manufacturer Narrative · 1

    (B)(4). ASP INVESTIGATION SUMMARY: THE INVESTIGATION INCLUDED A REVIEW OF THE COMPLAINT HISTORY TRENDING, SERVICE 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 FOR CIDEX ACTIVATED DIALDEHYDE SOLUTION WAS PERFORMED FOR THE PROBLEM CODES RELATED TO EYE BURNING, EYE REACTION, RESPIRATORY REACTION, AND HEADACHE, DID NOT REVEAL A SIGNIFICANT TREND. THERE WERE 9 COMPLAINTS OPENED IN (B)(4) 2011, 8 OF THE 9 TOTAL COMPLAINTS WERE RELATED TO THIS ONE EVENT WHICH DOES NOT REVEAL A SIGNIFICANT TREND. SERVICE HISTORY TRENDING FOR THE AER MACHINES SHOWS NO ISSUES WITH THE AER UNITS. THE TRENDING FOR PRODUCT BY PROBLEM CODES INDICATES NO SIGNIFICANT TREND WAS OBSERVED. A BATCH RECORD REVIEW OF THE CIDEX ACTIVATED DIALDEHYDE SOLUTION COULD NOT BE PERFORMED AS THE LOT NUMBER IS UNKNOWN AND THIS ISSUE IS NOT RELATED TO PRODUCT EFFICACY. 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. NO PRODUCT RETURNED FOR INVESTIGATION. THE CUSTOMER STATED THE FACILITY CHANGED TO CIDEX OPA SOLUTION AFTER THIS EVENT. THEY WERE USING CIDEX ACTIVATED DIALDEHYDE SOLUTION AT THE TIME OF THE EVENT.

    Description of Event or Problem · 1

    A CUSTOMER ALLEGED THAT HEALTHCARE WORKERS WERE REPORTING STINGING EYES WHEN WORKING IN THE AREA WHERE TWO ASP AER(S) ARE LOCATED. THE CUSTOMER DID NOT REQUEST SERVICE FOR THE UNITS. IT WAS STATED THAT THERE WAS NO PROBLEM WITH THE UNITS. THE CUSTOMER ALLEGED THAT THE HEALTHCARE WORKERS WERE LEAVING BOTTLES OPEN AND CLEANING SPILLS INCORRECTLY. THE HEALTHCARE WORKERS WERE RE-TRAINED ON PROPER PROCEDURE FOR WORKING IN THE AREA. THE AIR EXCHANGES OF THE ROOM HAVE BEEN TESTED AND PASSED. THERE IS NO MOLD IN THE ROOM. OTHER CHEMICALS IN THE ROOM INCLUDE ORTHOZONE AND ALCOHOL. ONE HEALTHCARE WORKER (HCW) ALLEGES A RESPIRATORY REACTION WHILE WORKING WITH THE AER(S) AND CIDEX ACTIVATED. THE HCW WAS DIAGNOSED WITH SINUSITIS THREE TIMES IN A TWO MONTH PERIOD. THE REPORTS OF SINUSITIS MAY BE INDEPENDENT EVENTS AS IT IS UNKNOWN IF THE EVENTS ARE ASSOCIATED WITH AER USE. THE HCW WAS TREATED WITH ANTIBIOTICS, AN INHALER AND NASAL SPRAY. IT IS REPORTED THAT THE HCW HAS A HISTORY OF SHORTNESS OF BREATH ONGOING SINCE 2005. OTHER ONGOING SYMPTOMS SINCE 2005 INCLUDE HEADACHE, DIZZINESS, LIGHTHEADED, NAUSEA, DRY NOSE, SINUS IRRITATION AND THROAT CONGESTION.

    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 45 YR