BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CIDEX OPA SOLUTION

    MDR report key: 2071179 · Received April 27, 2011

    Report

    Report Number
    2084725-2011-00032
    Event Type
    Injury
    Date Received
    April 27, 2011
    Date of Event
    April 1, 2011
    Report Date
    April 1, 2011
    Manufacturer
    ADVANCED STERILIZATION PRODUCTS
    Product Code
    MED
    PMA / PMN Number
    K991487
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    NOTE: THE MEDWATCH REPORT WAS SUBMITTED DUE TO MUCOUS MEMBRANE CONTACT. STAINING WAS ALSO REPORTED; HOWEVER, THE STAINING IS NOT THE REPORTABLE EVENT. THE INVESTIGATION WAS REVISED TO INCLUDE TRENDING AND IFU REVIEW FOR STAINING. ASP INVESTIGATION SUMMARY: THE INVESTIGATION INCLUDED A REVIEW OF THE COMPLAINT HISTORY TRENDING. COMPLAINT HISTORY TRENDING FOR CIDEX OPA FOR THE PROBLEM OF "HR-STAINING" IS NOT CONSIDERED A SIGNIFICANT TREND. IT IS SUSPECTED THAT THE STAINING REPORT IS A RESULT OF INADEQUATE CLEANING/RINSING OF THE DEVICE OR SOAKING THE DEVICE FOR EXTENSIVE PERIODS OF TIME. IT IS POSSIBLE THAT CIDEX OPA RESIDUE MAY BE PRESENT, LEADING TO STAINING OF THE PATIENT. THIS IS ONE OF TWO 3500A REPORTS BEING SUBMITTED FOR THIS PRODUCT MALFUNCTION. PLEASE REFERENCE MANUFACTURER REPORT NUMBERS: 2084725-2011-00032 AND 2084725-2011-00070.

    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 EVALUATION. COMPLAINT HISTORY TRENDING FOR CIDEX OPA FOR THE PROBLEM OF HR-MUCOUS MEMBRANE CONTACT IS NOT CONSIDERED A SIGNIFICANT TREND. BATCH RECORD REVIEW OF CIDEX OPA WAS NOT POSSIBLE SINCE THE LOT NUMBER WAS UNKNOWN. (B)(4). THERE WAS NO PRODUCT RETURNED AND THE LOT NUMBER WAS NOT AVAILABLE FOR RETAIN EVALUATION. MULTIPLE ATTEMPTS HAVE BEEN MADE BY THE AFFILIATE TO GATHER ADDITIONAL INFORMATION FROM THE HOSPITAL FOR THE REPORTED EVENT. THE HOSPITAL HAS BEEN UNCOOPERATIVE IN PROVIDING INFORMATION REGARDING THE EVENT AND THE PATIENT INVOLVED. DUE TO A LACK OF INFORMATION, AN ASSIGNABLE ROOT CAUSE CANNOT BE DETERMINED. THE CUSTOMER WAS INFORMED OF THE CIDEX OPA INSTRUCTIONS FOR USE (IFU) FOR SOAKING AND RINSING. USERS SHOULD RINSE THE PROBES ADEQUATELY TO REMOVE ALL CIDEX OPA RESIDUES. THE AFFILIATE REP WENT TO THE CUSTOMER'S SITE TO OBSERVE THE CSSD TECHNICIANS NORMAL PROCESSING OF A TOE PROBE FOR HIGH LEVEL DISINFECTION (HLC). IT WAS REPORTED THAT INCIDENTS HAVE BEEN REPORTED ONLY WITH THE TOE PROBES USED IN CARDIAC CATHETER LAB.

    Additional Manufacturer Narrative · 1

    NOTE: TOE AND TEE ARE INTERCHANGABLE TERMS. TEE IS MOST COMMONLY USED IN USA. THE CIDEX OPA INSTRUCTIONS FOR USE STATES IN SECTION C. SPECIAL INSTRUCTIONS FOR TRANSESOPHAGEAL ECHOCARDIOGRAPHY (TEE) PROBE REPROCESSING: AS WITH ALL DEVICES, CAREFULLY FOLLOW ALL PROBE MANUFACTURER RECOMMENDATIONS SUCH AS USE OF A STERILE PROTECTIVE SHEATH WHEN PERFORMING TEE. SOAKING FOR A MINIMUM OF 12 MINUTES IN CIDEX OPA SOLUTION IS REQUIRED FOR HIGH LEVEL DISINFECTION (HLD). EXCESSIVE SOAKING OF THE PROBES (E.G., LONGER THAN AN HOUR) DURING HLD AND/OR NOT RINSING THREE TIMES WITH A FRESH QUANTITY OF WATER EACH TIME AS DESCRIBED IN PART B, MAY RESULT IN RESIDUAL CIDEX OPA SOLUTION REMAINING ON THE DEVICE, THE USE OF WHICH MAY CAUSE STAINING, IRRITATION OR CHEMICAL BURNS OF THE MOUTH, THROAT, ESOPHAGUS AND STOMACH.

    Description of Event or Problem · 1

    A CUSTOMER REPORTED THAT THE TRANSOESOPHAGEAL ECHOCARDIOGRAPHY (TOE) PROBE DISINFECTED IN CIDEX OPA HAS BEEN ASSOCIATED WITH STAINING OF THE ORAL CAVITY AND ORAL BLISTERING AFTER MANUAL PROCESSING. THE STAINING APPEARS AS A "BLACK/GREEN" COLOR.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1