BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CIDEX OPA SOLUTION

    MDR report key: 5807004 · Received July 19, 2016

    Report

    Report Number
    2084725-2016-00416
    Event Type
    Injury
    Date Received
    July 19, 2016
    Date of Event
    June 20, 2016
    Report Date
    June 22, 2016
    Manufacturer
    ADVANCED STERILIZATION PRODUCTS
    Product Code
    MED
    PMA / PMN Number
    K991487
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SN
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    AFTER FURTHER CLARIFICATION, THIS PATIENT WAS NOT ADMITTED TO THE HOSPITAL RELATED TO THE SYMPTOMS REPORTED IN THIS EVENT. INSTEAD, PATIENT #3 WAS ALREADY ADMITTED PRIOR TO THE BRONCHOSCOPY WITH THESE ADMITTING DIAGNOSES: MEDIASTINAL MASS, TUBERCULOSIS ADENITIS. THE UPDATED REPORT FROM THE CUSTOMER NOTED PATIENT #3 HAD ONE FEBRILE EPISODE WHICH DEVELOPED 4-6 HOURS AFTER THE BRONCHOSCOPY. THE PATIENT WAS GIVEN AN ANTI-PYRETIC, AND THE FEVER RESOLVED AND DID NOT RECUR. NO CHEST X-RAY WAS DONE. THE CUSTOMER REPORTED THE BRONCHOSCOPES USED IN THE PROCEDURES WERE CULTURED. ONE OF THE SCOPES TESTED POSITIVE FOR STAPHYLOCOCCUS; HOWEVER IT IS UNKNOWN IF THIS SCOPE WAS USED ON PATIENT #3. THE HOSPITAL DID NOT PERFORM CULTURES ON PATIENT #3 RELATED TO THIS EVENT; IN ADDITION, IT WAS REPORTED THE PATIENT¿S FEVER HAD RESOLVED. THE CUSTOMER REPORTED AFTER THEIR INTERNAL INVESTIGATION, THEY DID NOT ATTRIBUTE THIS EVENT TO ASP PRODUCTS. THEY DID HOWEVER IMPLEMENT THE FOLLOWING INTERVENTIONS, AND REPORTED THEY HAVE HAD NO SIMILAR EVENTS AFTER THESE INTERVENTIONS WERE DONE. ADHERENCE TO CORRECT CLEANING METHODOLOGY. STRICT USE OF PERSONAL PROTECTIVE EQUIPMENT. EXECUTE THE DEVICE MANUFACTURER¿S GUIDELINES ON PROPER USE OF CLEANING AGENTS. PERFORM RANDOM CULTURES. REMOVED OLD SCOPES AND STARTING USING NEW ONES. AT THE TIME THE REPORTING DETERMINATION WAS MADE, A DECISION WAS MADE TO FILE A FDA MEDWATCH REPORT BASED ON THE LIMITED INFORMATION, AND DUE TO THE FACT THAT THE CUSTOMER REPORTED USING ASP PRODUCTS. HOWEVER, AFTER FURTHER INVESTIGATION AND BASED ON NEW INFORMATION RECEIVED ON 07/25/2016, THIS COMPLAINT IS DEEMED NOT REPORTABLE.

    Additional Manufacturer Narrative · 1

    BRAND NAME: CIDEZYME® ENZYMATIC DETERGENT. COMMON DEVICE: BIOCIDES SOLUTION. CATALOG #: 2292, CIDEZYME, 5 LITER. LOT # UNK, EXPIRATION: UNK.

    Description of Event or Problem · 1

    AN INTERNATIONAL AFFILIATE REPORTED THREE PATIENTS EXHIBITED FEVER, FIVE HOURS AFTER HAVING A BRONCHOSCOPY PROCEDURE, AND THE BRONCHOSCOPE WAS REPORTED TO HAVE BEEN CLEANED WITH CIDEZYME® ENZYMATIC DETERGENT AND HIGH LEVEL DISINFECTED WITH CIDEX® ACTIVATED SOLUTION. THIS REPORT IS FOR PATIENT #3 WHO HAD THE PROCEDURE DONE ON (B)(6) 2016. THE AFFILIATE REPORTED THE PATIENT WAS ADMITTED IN THE HOSPITAL WHEN THE PROCEDURE WAS DONE, AND THE EVENT WAS EXHIBITED. ADVANCED STERILIZATION PRODUCTS (ASP) HAS REQUESTED DETAILED INFORMATION REGARDING THIS EVENT; HOWEVER ASP HAS NOT RECEIVED ANYTHING FURTHER TO DATE. AT THE TIME THE REPORTING DETERMINATION WAS MADE, A DECISION WAS MADE TO FILE A FDA MEDWATCH REPORT BASED ON THE LIMITED INFORMATION IN THE COMPLAINT, AND DUE TO THE FACT THAT THE CUSTOMER REPORTED USING CIDEZYME® ENZYMATIC DETERGENT AND CIDEX® ACTIVATED SOLUTION FOR CLEANING AND DISINFECTION. HOWEVER, IT IS UNKNOWN WHETHER OR NOT THE SYMPTOMS REPORTED WERE RELATED. ASP WILL CONTINUE TO GATHER ADDITIONAL INFORMATION. PLEASE REFERENCE PATIENT #1: (B)(4). THIS IS SIX OF SIX REPORTS BEING SUBMITTED FOR THIS EVENT. PLEASE REFERENCE MANUFACTURER REPORT NUMBERS: 2084725-2016-00411, 2084725-2016-00412, 2084725-2016-00413, 2084725-2016-00414, 2084725-2016-00415, AND 2084725-2016-00416.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    460450 CIDEX OPA SOLUTION BIOCIDES SOLUTIONS (MED) MED ADVANCED STERILIZATION PRODUCTS NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization