BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STERIS SYSTEM 1

    MDR report key: 1511314 · Received October 20, 2009

    Report

    Report Number
    3000251274-2009-00016
    Event Type
    Malfunction
    Date Received
    October 20, 2009
    Date of Event
    September 20, 2009
    Report Date
    October 20, 2009
    Manufacturer
    STERIS CORPORATION - HOPKINS
    Product Code
    MED
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A STERIS SERVICE TECHNICIAN WHO INSPECTED THE SYSTEM 1 PROCESSOR FOUND THAT THE UNIT HAD BEEN STORED IN A WAREHOUSE FOR FOUR YEARS. THE PROCESSOR WAS NOT SERVICED PRIOR TO BEING PLACED BACK INTO SERVICE AND THIS INCIDENT OCCURRED ON THE FIRST DAY THE PROCESSOR WAS USED. THE STERIS SERVICE TECHNICIAN FOUND THAT THE PROCESSOR'S INFLATABLE LID SEAL WAS BADLY WORN, BUT NOT RUPTURED. HE ALSO FOUND THAT THE ASPIRATOR PROBE WAS BROKEN OFF AT THE END AND THE LID LATCH SHAFT BEARINGS WERE BADLY WORN AND CRACKED, CAUSING A POOR FIT BETWEEN THE LID AND UNIT. IN ADDITION, THE INCOMING BUILDING WATER PRESSURE TO THE PROCESSOR WAS SET AT 80 TO 100+ PSI AND THE REGULATOR ON THE PRE-FILTER WAS SET AT 65 PSI; THE REGULATOR SETTING IS SPECIFIED TO BE SET BETWEEN 40 TO 50 PSI. FOLLOWING EVALUATION, THE CUSTOMER REMOVED THE PROCESSOR FROM SERVICE.

    Additional Manufacturer Narrative · 1

    A STERIS ACCOUNT MANAGER OFFERED TO CONDUCT AN IN-SERVICE TRAINING FOR MEDICAL CENTER PERSONNEL REGARDING THE PROPER OPERATION OF THEIR SYSTEM 1 PROCESSORS HOWEVER, THE USER FACILITY HAS DECLINED THE IN-SERVICE. THE USER FACILITY WAS CONTACTED FOR FOLLOW-UP INFORMATION BUT NONE WAS PROVIDED.

    Description of Event or Problem · 1

    THE USER FACILITY REPORTED THAT AN EMPLOYEE'S CHEST, FACE AND ARMS CAME IN CONTACT WITH LIQUID FROM STERIS 20 STERILANT CONCENTRATE (S20) WHEN LIQUID FROM THE SYSTEM 1 PROCESSOR LEAKED OUT OF THE UNIT AND ONTO THE FLOOR. ACCORDING TO THE HOSPITAL, THIS OCCURRED WHEN THE EMPLOYEE BEGAN TO RUN A DIAGNOSTIC CYCLE IMPROPERLY USING AN S20 STERILANT CUP. THE EMPLOYEE WAS NOT WEARING PERSONAL PROTECTIVE EQUIPMENT (PPE) AT THE TIME OF THE INCIDENT. THE EMPLOYEE WAS TREATED IN THE FACILITY'S EMERGENCY ROOM, WHERE HER EYES WERE FLUSHED WITH SALINE AND STAINED TO CHECK FOR ABRASIONS. SHE ALSO RECEIVED A CHEST X-RAY FOR INHALATION OF FUMES. NO OTHER TREATMENT WAS REQUIRED. THE EMPLOYEE DID NOT MISS ANY TIME FROM WORK OR REQUIRE ANY FURTHER TREATMENT.

    Description of Event or Problem · 1

    COMPLICATIONS RELATED TO KIMBERLY CLARK PERCUTANEOUS G/GJ TUBE ANCHORS. OF THE 5 MOST RECENTLY PLACED PERCUTANEOUS GJ TUBES, WE HAVE HAD 4 ANCHOR RELATED COMPLICATIONS. THE INITIAL PTS HAD ANCHORS WHICH WENT THROUGH BOTH THE ANTERIOR AND POSTERIOR STOMACH WALL DURING INSERTION. THIS COMPLICATION WAS ADDRESSED BY PERFORMING ALL THE PROCEDURE WITH ENDOSCOPY TO CONFIRM THAT THE ANCHORS WERE INTRALUMINAL. DATES OF USE: (B) (6) 2009 - (B) (6) 2009. DIAGNOSIS OR REASON FOR USE: MEDICALLY COMPLEX.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 STERIS SYSTEM 1 LOW TEMPERATURE STERILIZER MED STERIS CORPORATION - HOPKINS 1271720 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Other