STERIS SYSTEM 1E

Report

Report Number: 3000251274-2012-00251
Date Received: November 29, 2012
Date of Event: October 30, 2012
Report Date: November 29, 2012
Manufacturer: STERIS CORPORATION - HOPKINS
Product Code: MED
PMA / PMN Number: K090036
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: TX, US
Reporter Occupation: OTHER HEALTH CARE PROFESSIONAL

Narratives

Additional Manufacturer Narrative · 1

A STERIS SERVICE TECHNICIAN INSPECTED THE AREA, AND FOUND NO WATER ON THE FLOOR BUT OBSERVED A TOWEL PLACED UNDER THE PRE A AND B FILTER ASSEMBLY. THE SERVICE TECHNICIAN INSPECTED THE EQUIPMENT, AND FOUND THE RUBBER WASHER IN THE UREBRADE HOSE FITTING WAS CUT THROUGH. THE TECHNICIAN INSPECTED THE FLAT OF THE ADAPTER AND FOUND NO BURR OR SHARP EDGE. THE TECHNICIAN REPLACED THE WASHER, AND RETHREADED THE HOSE FITTING ONTO THE ADAPTER. THE UNIT WAS TESTED, FOUND TO BE OPERATIONAL AND RETURNED TO SERVICE. ON (B)(4) 2012, STERIS CONTACTED THE FACILITY TO INQUIRE AS TO THE EMPLOYEE'S STATE OF HEALTH. THE CUSTOMER REPORTED THE EMPLOYEE WAS FINE. THE CAUSE OF THE LEAK AND SUBSEQUENT FLOOD WAS A CUT RUBBER WASHER INSIDE OF THE HOSE FITTING. THIS DAMAGE WAS CAUSED BY OVER-TIGHTENING OF THE HOSES ON THE PRE A AND B ADAPTERS.

Description of Event or Problem · 1

AN EMPLOYEE AT THE USER FACILITY HAD OBSERVED A PUDDLE ON THE FLOOR THE DAY BEFORE THE INCIDENT. THE EMPLOYEE WIPED UP THE WATER, BUT DID NOT TURN OFF THE WATER SUPPLY. THE LEAK CONTINUED OVER NIGHT, RESULTING IN A FLOOD WHERE THE SYSTEM 1E IS LOCATED. THE USER FACILITY REPORTED AN EMPLOYEE TWISTED HER LEG DUE TO WATER ON THE FLOOR OF THE ROOM WHERE THE SYSTEM 1E IS LOCATED. THE EMPLOYEE DID NOT SEEK MEDICAL ATTENTION. NO PROCEDURES WERE DELAYED OR CANCELLED.

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