BEUDAMED
    FDA Adverse Event Summary report: N

    STERIS SYSTEM 1E

    MDR report key: 4032244 · Received August 25, 2014

    Report

    Report Number
    3000251274-2014-00069
    Date Received
    August 25, 2014
    Date of Event
    July 23, 2014
    Report Date
    August 22, 2014
    Manufacturer
    STERIS CORPORATION - HOPKINS
    Product Code
    MED
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION OF THIS EVENT IS CURRENTLY IN PROCESS. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Additional Manufacturer Narrative · 1

    A STERIS SERVICE TECHNICIAN ARRIVED AT THE FACILITY, INSPECTED THE SYSTEM 1E, AND CONFIRMED THERE WAS A LARGE AMOUNT OF WATER PRESENT IN THE UNIT'S DRIP PAN. IN ADDITION, THE TECHNICIAN OBSERVED A BLACK MATERIAL FLOATING IN THE DRIP PAN WATER, ON THE EDGES OF THE UNIT'S INFLATABLE SEAL AND UNDER THE SEAL HOLDERS. THE MATERIAL APPEARED TO BE A FUNGAL FILM ORIGINATING FROM THE BOTTOM OF THE UNIT'S DRIP PAN. THE MATERIAL ALSO APPEARED ON THE SEAL HOLDERS AS WELL AS ON THE SEAL ITSELF. THE AMOUNT OF WATER IDENTIFIED IN THE FACILITY'S DRIP PAN IS INDICATIVE OF IMPROPER DAILY CLEANING PRACTICES AS SPECIFIED IN THE SYSTEM 1E OPERATOR MANUAL. THE SYSTEM 1E OPERATOR MANUAL (9-1) CONTAINS INFORMATION REGARDING DAILY CLEANING AND CHECKS TO BE PERFORMED BY THE SYSTEM 1E OPERATORS. THE OPERATOR MANUAL STATES, "STEP 3 CLEAN PROCESSING TRAY - WIPE THE INNER SURFACE AND SEAL, PROCESSING TRAY/CONTAINER, AND ACCESSORY RACK WITH A SOFT CLOTH DAMPENED WITH 70% ISOPROPYL ALCOHOL." FURTHER, "STEP 6 CHECK DRAIN SCREEN - THE DRAIN SCREEN IS LOCATED IN THE BOTTOM OF THE STERILANT COMPARTMENT. ENSURE THAT THE SCREEN IS CLEAN... THE SCREEN MAY BE REMOVED FOR THOROUGH CLEANING BY LIFTING THE PROCESSING TRAY AND UNSCREWING THE DROGUE. REPLACE SCREEN AFTER CLEANING." THE STERIS TECHNICIAN REMOVED AND REPLACED THE INFLATABLE SEAL AND CLEANED THE DRIP PAN INTERIOR, DROGUES AND SEAL HOLDERS WITH ISOPROPYL ALCOHOL. THE STERIS TECHNICIAN MET WITH THE FACILITY'S INFECTION CONTROL PERSONNEL WHO STATED THERE WERE NO REPORTS OF PATIENT COMPLICATIONS OR DELAYED PROCEDURES AS A RESULT OF THE FILM. THE SYSTEM 1E CYCLES COMPLETED SUCCESSFULLY. STERIS WAS NOT NOTIFIED AS TO WHETHER SAMPLES OF THE BLACK MATERIAL WERE CULTURED FOR IDENTIFICATION BY THE FACILITY'S INFECTION CONTROL DEPARTMENT. IN ADDITION, THE TECHNICIAN IDENTIFIED THE STERILE AIR FILTER WAS NOT LOCATED IN THE SYSTEM 1E. THE STERILE AIR FILTER IS INSTALLED WITH ALL SYSTEM 1E PROCESSING SYSTEMS. STERIS QUALITY CONTACTED THE TECHNICIAN WHO SERVICED THE SYSTEM 1E PRIOR TO THE REPORTED EVENT. THE TECHNICIAN STATED THAT THE AIR FILTER WAS INSTALLED WHILE HE WAS ONSITE, HOWEVER HE HAD SEEN THE AIR FILTER REMOVED BY FACILITY PERSONNEL ON PREVIOUS SERVICE VISITS TO THE FACILITY. WHEN THIS WAS OBSERVED, THE TECHNICIAN PLACED AN AIR FILTER INTO THE UNIT. THE TECHNICIAN WAS UNABLE TO DETERMINE WHEN THE AIR FILTER WAS REMOVED BY THE FACILITY'S PERSONNEL. A NEW STERILE AIR FILTER WAS INSTALLED AND THE MAXPURE FILTER WAS REPLACED. SECTION 9 OF THE SYSTEM 1E OPERATOR MANUAL INSTRUCTS THE USER TO CHANGE THE STERILE AIR FILTER EVERY SIX MONTHS. AFTER CLEANING AND INSTALLING THE NEW PARTS, THE TECHNICIAN COMPLETED A DIAGNOSTIC AND PROCESSING CYCLE AND CONFIRMED THE UNIT WAS OPERATING ACCORDING TO SPECIFICATIONS. WHILE ONSITE, THE TECHNICIAN DISCUSSED THE IMPORTANCE OF THE DAILY CLEANING MAINTENANCE AS OUTLINED IN SECTION 9 OF THE SYSTEM 1E OPERATOR MANUAL. IN ADDITION, A STERIS ACCOUNT MANAGER PERFORMED IN-SERVICE TRAINING ON THE PROPER USE AND OPERATION OF THE SYSTEM 1E INCLUDING THE IMPORTANCE OF ALL FILTERS. THE ACCOUNT MANAGER MARKED EACH AIR FILTER WITH THE RECOMMENDED CHANGE OUT DATE, AND ADDRESSED THE IMPORTANCE OF MONITORING THE MAX PURE FILTERS THROUGH DIAGNOSTIC CYCLES. THE ACCOUNT MANAGER ALSO PROVIDED AN ADDITIONAL SYSTEM 1E MAINTENANCE MANUAL TO BE PLACED WITH THE SYSTEM 1E IN THE PROCESSING AREA. THE SYSTEM 1E IS CURRENTLY UNDER A STERIS SERVICE CONTRACT. THE LAST PREVENTIVE MAINTENANCE WAS PERFORMED ON MAY 13, 2014 AT WHICH TIME THE UNIT WAS CONFIRMED TO BE OPERATING TO SPECIFICATION. NO FURTHER ISSUES HAVE BEEN REPORTED.

    Description of Event or Problem · 1

    THE USER FACILITY REPORTED WATER IN THE DRIP PAN OF THEIR SYSTEM 1E.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    511839 STERIS SYSTEM 1E LIQUID CHEMICAL STERILANT PROCESSING SYSTEM MED STERIS CORPORATION - HOPKINS

    Patients

    Seq Age Sex Outcome Treatment
    1 Other