FDA.reportPublic FDA data

MAUDE MDR 6312588

MDR report key
6312588
Report number
1937531-2017-00002
Event key
0
Event type
3
Date of event
2017-01-09
Date received
2017-02-08
Adverse event
3
Product problem
3
Patients in event
0
Reporter occupation
0
Health professional
3
Initial report to FDA
3
Event location
3

Manufacturer Contact#

Contact
MS. KATHRYN CADORETTE
Address
5960 HEISLEY ROAD MENTOR OH 44060 US
Phone
440-440-4403
Report source
M
Manufacturer link flag
Y

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1ETHYLENE OXIDE STERILANTETHYLENE-OXIDE GAS TO 3017 ETO STERILIZERSTERIS CORPORATIONFLF280616Y Y

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12017-02-0801. O

Event Narratives#

N

Patient 1

THE STERILIZER OPERATED PROPERLY WHEN THE EO CARTRIDGE LEAK WAS DETECTED. AN EXHAUST AND AIR WASH SEQUENCE IN THE STERILIZER OCCURRED AND THE CHAMBER DOOR REMAINED LOCKED. WHEN THIS SEQUENCE OCCURS ONLY A QUALIFIED SERVICEMAN CAN UNLOCK THE CHAMBER DOOR. A STERIS SERVICE TECHNICIAN ARRIVED ONSITE TO INSPECT THE STERILIZER. DURING THE TECHNICIAN'S INSPECTION, HE CONFIRMED THE 3017 ETO STERILIZER HAD ALARMED FOR AN EO CARTRIDGE LEAK. THE TECHNICIAN TESTED THE STERILIZER AND FOUND IT TO BE OPERATING PROPERLY. NO ISSUES WERE NOTED WITH THE STERILIZER AND THE UNIT WAS RETURNED TO SERVICE. THE OPERATOR MANUAL STATES (PP. 6-6), "THE CHAMBER DOOR(S) REMAINS LOCKED UNTIL COMPLETION OF THE PROGRAMMED EXHAUST OR AERATION PHASE OR DURING POWER FAILURE." THE OPERATOR MANUAL STATES (PP. 2-2), "THE DOOR LOCK REMAINS LOCKED THROUGHOUT THE ENTIRE CYCLE, EVEN IF POWER IS REMOVED, NO MATTER WHAT THE CHAMBER PRESSURE IS. THE CHAMBER DOOR CANNOT BE OPENED IF THE LOCK IS ENGAGED." THE OPERATOR MANUAL STATES (PP. 2-3), "THE CHAMBER TEMPERATURE AND VACUUM ARE CONTINUALLY MONITORED THROUGHOUT THE CYCLE, AND IN THE EVENT OF ANY ABNORMALITY, THE NORMAL EXHAUST AND AIR WASH SEQUENCE IS PERFORMED BEFORE THE DOOR IS UNLOCKED." INVESTIGATION OF THIS EVENT IS CURRENTLY IN PROCESS TO DETERMINE THE CAUSE OF THE EO CARTRIDGE LEAK. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE INVESTIGATION IS COMPLETED.

D

Patient 1

THE USER FACILITY REPORTED THEIR 3017 ETO STERILIZER ALARMED FOR AN EO CARTRIDGE LEAK. NO INJURY, PROCEDURE DELAYS OR CANCELLATIONS WERE REPORTED.

N

Patient 1

DURING STERIS' INVESTIGATION OF THE REPORTED EVENT, IT WAS DETERMINED THAT THE EO CARTRIDGE LEAK WAS CONTAINED WITHIN THE STERILIZER AND NO EO LEAKED OUTSIDE OF THE UNIT. THE STERILIZER OPERATED PROPERLY WHEN THE EO CARTRIDGE LEAK WAS DETECTED. AN EXHAUST AND AIR WASH SEQUENCE IN THE STERILIZER OCCURRED AND THE CHAMBER DOOR REMAINED LOCKED. WHEN THIS SEQUENCE OCCURS ONLY A QUALIFIED SERVICEMAN CAN UNLOCK THE CHAMBER DOOR. THE STERIS TECHNICIAN TESTED THE UNIT AND CONFIRMED IT TO BE OPERATING PROPERLY. THE UNIT WAS RETURNED TO SERVICE AND NO ADDITIONAL ISSUES HAVE BEEN REPORTED.