BEUDAMED
    FDA Adverse Event Injury Summary report: N

    3633

    MDR report key: 5747546 · Received June 24, 2016

    Report

    Report Number
    3004147784-2016-00001
    Event Type
    Injury
    Date Received
    June 24, 2016
    Date of Event
    May 26, 2016
    Report Date
    May 26, 2016
    Manufacturer
    GETINGE SOURCING LLC
    Product Code
    FLE
    Adverse Event
    Yes
    Report Source
    Distributor report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE STERILIZER WAS INSTALLED IN (B)(6) AND AS INFORMED IT WAS USED ONLY FOR SCIENTIFIC AND NOT MEDICAL PURPOSES. EVEN THOUGH THE EVENT TOOK PLACE AT THE UNIVERSITY, AND THE MACHINE WAS USED FOR SCIENTIFIC PURPOSES, THE DEVICE IS AN OBSOLETE UNIT, MANUFACTURED IN 1995, WE REPORT THIS IN ABUNDANCE OF CAUTION BECAUSE AT THE TIME, IN OUR OFFER OF STERILIZER DEVICES TO THE CUSTOMER WE DID NOT MAKE THE DISTINCTION BETWEEN DEVICES MEANT FOR MEDICAL USES AND THOSE NOT USED FOR MEDICAL USES - THE LATTER BEING THE CASE HERE. THE PERSON INVOLVED IN THE EVENT WAS TREATED FOR 1ST DEGREE BURN ON HIS SHOULDER AND RELEASED. IN OUR EVALUATION, THE SEVERITY IN THIS CASE IS EQUAL 2 (BURN/SCALD ASSOCIATED WITH A SMALL AREA OF THE BODY (< 5% TBSA) AND NOT AFFECTING DEEP DERMAL STRUCTURES (1ST OR 2ND DEGREE). IS NOT CONSIDERED LIKELY TO BE LIFE THREATENING REQUIRING BASIC TREATMENT. BASED ON THIS WE DO NOT CONSIDER THE INJURY TO BE A SERIOUS INJURY, HOWEVER WE REPORT THIS INCIDENT IN ABUNDANCE OF CAUTION. THE LIQUID CYCLE THAT WAS USED HERE IS A SPECIAL PROGRAM, INTENDED TO STERILIZE VESSELS WITH LIQUID SUBSTANCES IN LIFE SCIENCE FILED. THE CYCLE HAS DIFFERENT PROCESS PARAMETERS AND REQUIRES ADDITIONAL SAFETY PRECAUTIONS. USERS ARE INFORMED IN THE USER MANUAL OF NECESSITY TO REMAIN CAREFUL WHEN UNLOADING HOT LIQUIDS FROM THE STERILIZER. THE USER MANUAL OF 3633 MODEL PROVIDES GUIDANCE ON HOW TO SAFELY UNLOAD THE STERILIZER AFTER PERFORMING A LIQUID CYCLE (PAGE 3-9, 350113 MANUAL(O)-MC3622/23/33): "11. REMOVE THE LOAD. BECAUSE OF THE LARGE MASS OF A LIQUID LOAD, ADDITIONAL COOLING IS REQUIRED TO PREVENT POSSIBLE THERMAL SHOCK OR BOILING OVER WHEN DOOR IS OPENED TO REMOVE THE LOAD.(...) PRESS OPEN DOOR WHEN UPPER HOOK STARTS TO RISE. THEN PRESS CLOSE DOOR. THIS WILL UNSEAL THE DOOR GASKET AND PERMIT STEAM TO ESCAPE FROM THE TOP OF THE DOOR. ALLOW AT LEAST 15 MINUTES MORE TO COOL. PRESS OPEN DOOR. CAREFULLY REMOVE THE LOAD." THE DEVICE OPERATOR AFTER HAVING REMOVED THE RACK FROM THE CHAMBER AND PLACING IT ONTO THE TROLLEY IMMEDIATELY TRIED TO TAKE THE PAN WITH THE FLASKS OFF THE RACK WHICH LED TO SPUTTERING AND THE ACCIDENT. THE OPERATORS SHOULD ALWAYS ALLOW THE LOAD TO COOL FOR 15 MIN AS ADVISED IN THE USER MANUAL AS A SAFETY PRECAUTION. THE DEVICE OPERATOR OPENED THE STERILIZER DOOR RIGHT AFTER THE PROCESS COMPLETION, BUT SHOULD HAVE WAITED FOR 15 MINUTES AS WARNED IN USER MANUAL. AS FOUND, THE STERILIZED LOAD CONTAINED LARGE FLASKS OF 2000ML FULL OF LIQUID. THIS AMOUNT OF WATER BASED SOLUTIONS IS HIGH LIKELY TO BOIL OVER AND SPUTTER AS A RESULT OF THERMAL SHOCK IF TAKEN OUT FROM THE STERILIZER TO SOON AND WITHOUT ALLOWING EXTRA COOLING. THE STERILIZER 3633 WAS CHECKED AFTER THE INCIDENT BY THE GETINGE SERVICE TECHNICIAN, WHO CONFIRMED THAT THE DEVICE WORKS UP TO THE MANUFACTURER SPECIFICATION AND THE ACCIDENT HAPPENED AS A RESULT OF THE USER ERROR. THE STERILIZER DID NOT MALFUNCTION WHEN THE EVENT OCCURRED. AS STATED BY THE TECHNICIAN, THE DEVICE WAS FOUND FULLY OPERATIONAL WHEN TESTED AFTER THE INCIDENT. THEREFORE, IT APPEARS THERE HAS BEEN NO TECHNICAL DEFICIENCY WITH THE DEVICE AND THAT A USE ERROR CAUSED THE EVENT, THE MOST RELEVANT USE ERROR BEING WRONG HANDLING OF THE FLASKS OFF THE RACK AFTER THE LIQUID PROCESS, NOT FOLLOWING WARNINGS PROVIDED IN USE MANUAL. WHEN THE USER MANUAL WOULD HAVE BEEN FOLLOWED, IT IS CONSIDERED HIGHLY PROBABLE THAT THIS EVENT WOULD HAVE BEEN AVOIDED.

    Description of Event or Problem · 1

    ON MAY 26, 2016 GETINGE IC PRODUCTION RECEIVED A CUSTOMER COMPLAINT WITH AN INCIDENT REPORT WHERE AS STATED, THE PERSON WAS INJURED BY THE STEAM WHICH SPUTTERED FROM THE FLASK FULL OF STERILIZED LIQUID AFTER THE LOAD FROM THE RACK WAS PULLED OUT OF THE CHAMBER ONTO THE TROLLEY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    402365 3633 FLE FLE GETINGE SOURCING LLC 3633

    Patients

    Seq Age Sex Outcome Treatment
    1 20 YR Hospitalization