BEUDAMED
    FDA Adverse Event Death Summary report: N

    STERIS SYSTEM 1E

    MDR report key: 2482937 · Received March 7, 2012

    Report

    Report Number
    3000251274-2012-00044
    Event Type
    Death
    Date Received
    March 7, 2012
    Date of Event
    March 1, 2012
    Report Date
    March 7, 2012
    Manufacturer
    STERIS CORPORATION - HOPKINS
    Product Code
    MED
    PMA / PMN Number
    K090036
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    AS THE FOLLOWING SHOWS, THE INFORMATION CURRENTLY AVAILABLE TO STERIS DOES NOT REQUIRE THE SUBMISSION OF A MEDICAL DEVICE REPORT TO FDA UNDER 21 CFR PART 803 FOR THE FOUR EVENTS REPORTED TO THE COMPANY BY THE USER FACILITY. NONETHELESS, ERRING ON THE SIDE OF CAUTION, AND WITH AN INTEREST TO KEEP FDA APPRISED OF THIS SITUATION, STERIS IS SUBMITTING THIS MDR. THE FOLLOWING DESCRIBES OUR INSPECTIONAL FINDINGS TO DATE. STERIS FIELD SERVICE AND CLINICAL SUPPORT STAFF VISITED THE USER TO INVESTIGATE THE REPORTED CIRCUMSTANCES AND ASSIST THE USER FACILITY. STERIS SERVICE TECHNICIANS INSPECTED THE FACILITY'S TWO SYSTEM 1E PROCESSORS AND FOUND THE FOLLOWING: STERIS'S TECHNICIANS RAN DIAGNOSTIC AND PROCESSING CYCLES OF THE FACILITY'S TWO SYSTEM 1E PROCESSORS AND DETERMINED THAT BOTH UNITS WERE OPERATING PROPERLY. THE SYSTEM 1E CYCLE PRINT-OUTS FOR EACH OF THE PROCESSING CYCLES OF THE BRONCHOSCOPE USED ON THE ALLEGEDLY INFECTED PATIENTS CONFIRMED THAT THE REQUIRED CYCLE PARAMETERS FOR EACH SUCH CYCLE WERE MET. THE USER FACILITY REPORTED THAT THE CHEMICAL INDICATORS USED TO MONITOR EACH IMPLICATED CYCLES SHOWED EACH SUCH CYCLE HAD PASSING RESULTS. STERIS TECHNICIANS DOCUMENTED THAT THE VERIFY SYSTEM 1E CHEMICAL INDICATORS USED TO MONITOR THE IMPLICATED PROCESSING CYCLES OF THE BRONCHOSCOPE WERE WITHIN THEIR LABELED EXPIRATION DATES AND THAT THE SAME LOT NUMBER OF STERIS CHEMICAL INDICATORS WAS USED THROUGHOUT THE PERIOD OF THE REPORTED EVENTS. THE FACILITY DID NOT RECORD THE LOT NUMBERS OF THE S40 STERILANT CONCENTRATE USED, HOWEVER, STERIS CONFIRMED DURING ITS VISIT TO THE FACILITY THAT ALL S40 ON HAND WAS WITHIN ITS LABELED EXPIRATION DATE. A STERIS CLINICAL SUPPORT SPECIALIST INTERVIEWED STAFF FROM THE FACILITY'S CENTRAL SERVICES, SURGICAL SUPPORT AND INFECTION CONTROL DEPARTMENTS AND ALSO REVIEWED THE FACILITY'S PRACTICES. BASED UPON THE FACILITY'S DESCRIPTION OF THEIR PRACTICES WITH RESPECT TO SYSTEM 1E, IT APPEARED THAT THE PROCESSORS WERE BEING USED CORRECTLY AND THAT THE FACILITY WAS USING THE APPROPRIATE QUICK CONNECT FOR THE REFERENCED OLYMPUS BRONCHOSCOPE. IN SUM, THE INFORMATION PROVIDED TO STERIS SUPPORTS THE CONCLUSION THAT THE FACILITY'S SYSTEM 1E PROCESSORS WERE FUNCTIONING PROPERLY, THAT THE PROPER STERILANT, CHEMICAL INDICATORS AND QUICK CONNECTS WERE USED, AND THE USER FACILITY REPORTED OPERATING THE PROCESSORS ACCORDING TO THE DEVICE USER INSTRUCTIONS. WHILE CONDUCTING THE COMPLAINT INVESTIGATION, THE USER FACILITY STAFF REPORTED THE FOLLOWING INFORMATION TO THE STERIS CLINICAL AND FIELD SERVICE STAFF: EACH PROCEDURE WAS PERFORMED BETWEEN (B)(6) 2010 - (B)(6) 2012 USING THE SAME OLYMPUS BRONCHOSCOPE MODEL BFQ-180. ON (B)(6) 2012, THE BRONCHOSCOPE FAILED LEAK TESTING AND WAS RETURNED TO OLYMPUS FOR REPAIR. THE HOSPITAL REPORTED THAT ITS STANDARD PRACTICE IS TO LEAK TEST ALL ENDOSCOPES BEFORE PROCESSING IN SYSTEM 1E, ALTHOUGH MOST ENDOSCOPE LEAK TESTS USED IN THE CLINICAL CONTEXT HAVE A MINIMUM DETECTION VALUE BELOW WHICH VERY SMALL LEAKS MAY OCCUR WITHOUT DETECTION. IT WAS REPORTED THAT THE PRACTICE AT THIS HOSPITAL IS TO HANG UP SCOPES AFTER PROCESSING UNTIL NEEDED; SYSTEM 1E LABELING EXPRESSLY AND PROMINENTLY REQUIRES THAT PROCESSED MEDICAL DEVICES SHOULD BE USED IMMEDIATELY. EACH PATIENT'S PROCEDURE WAS PERFORMED BY THE SAME PHYSICIAN. STERIS WAS ADVISED BY HOSPITAL STAFF THAT THE PHYSICIAN'S PRACTICE DURING THE PROCEDURES WAS TO COOL STERILE PHYSIOLOGICAL SALINE SOLUTION BY MIXING IT WITH NON-STERILE ICE. THE MIXED SOLUTION WAS THEN REPORTEDLY UTILIZED TO IRRIGATE PATIENTS DURING BRONCHOSCOPY. THE USER FACILITY RECEIVED A LOANER BRONCHOSCOPE FOR USE WHILE ITS SCOPE WAS BEING REPAIRED. THE USER FACILITY STERILE SWABBED THE SUCTION AND BIOPSY PORTS OF THE LOANER BRONCHOSCOPE AFTER PROCESSING IN SYSTEM 1E. THE CULTURING OF THE SAMPLE WAS REPORTED TO SHOW NO GROWTH. STERIS'S INVESTIGATION SUGGESTS THAT THE FACILITY'S SYSTEM 1ES WERE OPERATING IN ACCORDANCE WITH THEIR DESIGN SPECIFICATIONS AND IN FACT MET APPROPRIATE SUCCESSFUL CYCLE PARAMETERS FOR EACH PROCESSING CYCLE RELATING TO THE REFERENCED PATIENTS. ADDITIONALLY, STERIS'S INVESTIGATION SHOWS THAT THE FACILITY'S PRACTICES DID NOT CONFORM TO SYSTEM 1E LABELING, E.G., HANGING THE BRONCHOSCOPE AFTER PROCESSING FOR UNSPECIFIED PERIODS, I.E., UNTIL NEEDED FOR A NEXT PATIENT PROCEDURE. THE USER FACILITY IS CONTINUING TO INVESTIGATE THE CAUSE OF THE REPORTED EVENTS. THE FACILITY INFECTION CONTROL NURSE STATED TO THE STERIS CLINICAL SPECIALIST THAT IN HER OPINION USE OF THE SYSTEM 1E PROCESSORS DID NOT CAUSE OR CONTRIBUTE TO THE REPORTED EVENTS. WHILE THE INFORMATION KNOWN TO STERIS DOES NOT SHOW THAT A STERIS DEVICE CAUSED OR CONTRIBUTED TO A DEATH OR SERIOUS INJURY OR THAT A MALFUNCTION OCCURRED, STERIS IS SUBMITTING THIS REPORT OUT OF AN ABUNDANCE OF CAUTION TO ENSURE THAT FDA IS AWARE OF THESE ALLEGED EVENTS.

    Description of Event or Problem · 1

    THE USER FACILITY REPORTED THAT SPUTUM SAMPLES FROM FOUR PATIENTS WHO UNDERWENT BRONCHOSCOPIC PROCEDURES DURING (B)(6) 2012 CONTAINED SERRATIA WHICH AT THIS TIME HAS NOT BEEN GENOTYPICALLY SPECIATED; ONE PATIENT WAS REPORTED TO HAVE SERRATIA IN THEIR SPUTUM AT THE TIME OF HOSPITAL ADMITTANCE. TWO PATIENTS REPORTEDLY DIED; HOWEVER, THE DEATHS ARE NOT BEING ATTRIBUTED BY THE HOSPITAL STAFF TO THE SYSTEM 1E. SPECIFICALLY, THE HOSPITAL STAFF REPORTED THAT THE CAUSE(S) OF THE DEATHS HAS NOT BEEN DETERMINED. THE PROCEDURES ASSOCIATED WITH THE ADVERSE EVENTS WERE PERFORMED USING THE SAME OLYMPUS BRONCHOSCOPE MODEL BFQ-180 THAT WAS LIQUID CHEMICALLY STERILIZED USING A SYSTEM 1E PROCESSOR AT A TIME PRIOR TO THE PROCEDURE; THE USER FACILITY HAS TWO (2) SYSTEM 1E PROCESSORS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 STERIS SYSTEM 1E LIQUID CHEMICAL STERILANT PROCESSING SYSTEM MED STERIS CORPORATION - HOPKINS

    Patients

    Seq Age Sex Outcome Treatment
    1 Other