BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CIDEX OPA SOLUTION

    MDR report key: 1664324 · Received April 21, 2010

    Report

    Report Number
    2084725-2010-00130
    Event Type
    Malfunction
    Date Received
    April 21, 2010
    Date of Event
    March 1, 2010
    Report Date
    March 26, 2010
    Manufacturer
    ADVANCED STERILIZATION PRODUCTS
    Product Code
    MED
    PMA / PMN Number
    K991487
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ASP INVESTIGATION RESULTS: A BATCH REVIEW AND RETAIN SAMPLE TESTING OF LOT 120209/084 WAS PERFORMED BY THE MANUFACTURER (B)(4). THE LOT WAS REPORTED TO HAVE BEEN MANUFACTURED TO SPECIFICATIONS WITH NO ANOMALIES, AND RETAIN SAMPLES TESTING AGAINST RELEASE SPECIFICATIONS FOR CIDEX OPA CONTENT, BENZOTRIAZOLE CONTENT, PH, COLOR, AND APPEARANCE ALL MET SPECIFICATIONS. BASED ON THE INFORMATION PROVIDED, THE POTENTIAL CAUSE OF THE REPORTED ALLERGIC SYMPTOMS IS DUE TO INADEQUATE VENTILATION IN THE ROOM. THE CIDEX OPA INSTRUCTIONS FOR USE STATE TO USE IN WELL-VENTILATED AREA, AND IN CLOSED CONTAINERS WITH TIGHT-FITTING LIDS. THE CIDEX OPA FMEA AND SHUMA WERE REVIEWED. (B)(4). A REVIEW OF THE COMPLAINT HISTORY FOR LOT 120209084 DID NOT REVEAL ANY SIMILAR REPORTED COMPLAINTS OTHER THAN THOSE REPORTED BY THIS FACILITY. A REVIEW OF THE COMPLAINT HISTORY OVER THE PAST 12 MONTHS ((B)(6) 2009 TO (B)(6) 2010) FOR CIDEX OPA SOLUTION WITH THE PROBLEM CODE OF "HR - ALLERGIC SYMPTOMS"INDICATED A DECREASING TREND. A CAPA WAS OPENED TO INVESTIGATE HEALTHCARE WORKER 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. AS PART OF THE CAPA ACTION PLAN, THE CIDEX OPA WALL CHART WAS UPDATED AND AN ACCOMPANYING COMMUNICATION LETTER WAS SENT TO CUSTOMERS, WITH REMINDERS TO USE CIDEX OPA SOLUTION IN A WELL-VENTILATED AREA AND A REMINDER TO FOLLOW THE INSTRUCTIONS FOR USE. IN ADDITION, ASP PLANS TO ESTABLISH AN OCCUPATIONAL EXPOSURE LEVEL (OEL) FOR CIDEX OPA SOLUTION AS PART OF THE CAPA ACTION PLAN.

    Additional Manufacturer Narrative · 1

    CORRECTION: CHANGED EVENT TYPE TO PRODUCT PROBLEM DEVICE.

    Additional Manufacturer Narrative · 1

    THIS IS THREE OF THREE 3500A REPORTS BEING SUBMITTED FOR THIS PRODUCT MALFUNCTION. PLEASE REFERENCE MANUFACTURER REPORT NUMBERS: 2084725-2010-00128; 2084725-2010-00129 AND 2084725-2010-00130.

    Description of Event or Problem · 1

    AS REPORTED BY THE (B)(6): THE TARGET LESION WAS A 99% STENOSIS IN THE PROXIMAL LEFT INTERNAL CAROTID ARTERY. A 5MM ANGIOGUARD DEVICE WAS ADVANCED BEYOND THE TARGET AND WAS DEPLOYED WITHOUT DIFFICULTY. A 6.0 X 30MM PRECISE STENT WAS DEPLOYED SUCCESSFULLY. FOLLOWING STENT DEPLOYMENT THE PATIENT EXPERIENCED APHASIA, HEMIPARESIS ON THE RIGHT. THE ANGIOGUARD WAS RETRIEVED AND DEBRIS WAS OBSERVED WITHIN THE FILTER BASKET. THE EVENT ONSET WAS SUDDEN AND RECOVERY WAS PARTIAL WITH MAJOR RESIDUAL. DIAGNOSIS WAS ISCHEMIC STROKE.

    Description of Event or Problem · 1

    IT IS REPORTED THAT A HEALTHCARE WORKER (HCW) HAS DISPLAYED SYMPTOMS OF HEADACHE, EYE IRRITATION AND CORIZA (RUNNY NOSE). THE HCW DID SEEK MEDICAL ATTENTION WITH NO PRESCRIBED TREATMENT. THE HCW EYES WERE WASHED WITH A PHYSIOLOGIC SOLUTION. THE HCW WORKS IN AN ENDOSCOPY AREA FOUR OR MORE HOURS PERFORMING MANUAL REPROCESSING. THE AREA IS DESCRIBED AS VERY SMALL WITH NO VENTILATION OR EXHAUST SYSTEM. THE ROOM TEMPERATURE IS ABOUT 35DEGREES CELCIUS. CIDEX OPA IS USED IN A PLASTIC CONTANINER WITH A BROKEN COVER IN A VOLUME OF 2 GALLONS. THE HCW DOES WEAR A MASK, SAFETY GLASSES AND SPECIFIC CLOTHING. THIS IS REPORT THREE OF THREE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CIDEX OPA SOLUTION BIOCIDES SOLUTIONS (MED) MED ADVANCED STERILIZATION PRODUCTS 120209084

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR