V-PRO 1 PLUS STERILIZER

Report

Report Number: 3005899764-2014-00026
Date Received: May 15, 2014
Date of Event: April 17, 2014
Report Date: May 15, 2014
Manufacturer: STERIS MEXICO, S. DE R.L. DE C.V.
Product Code: MLR
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: MI, US
Reporter Occupation: OTHER HEALTH CARE PROFESSIONAL

Narratives

Additional Manufacturer Narrative · 1

ONE OF THE EMPLOYEES EXPOSED TO THE V-PRO 1 PLUS VAPORS VISITED OCCUPATIONAL HEALTH DUE TO THE EYE IRRITATION. THE INDIVIDUAL WAS GIVEN EYE DROPS WITH STEROIDS AND RETURNED TO WORK. ANOTHER INDIVIDUAL FLUSHED HIS EYES AT AN EYEWASH STATION FOLLOWING THE EVENT. ALL OTHER PERSONNEL IN THE ROOM LEFT THE DEPARTMENT IN ORDER TO GET FRESH AIR. ALL EMPLOYEES RETURNED BACK TO WORK LATER THAT DAY. A STERIS SERVICE TECHNICIAN ARRIVED AT THE FACILITY, INSPECTED THE V-PRO 1 PLUS STERILIZER AND FOUND THE ROOT CAUSE OF THE CANCELLED CYCLE WAS FAILURE OF THE SV-4 INJECTION VALVE. THE TECHNICIAN FOUND THE INJECTION VALVE HAD INJECTED THE FULL RESERVOIR OF HYDROGEN PEROXIDE INTO THE CHAMBER INSTEAD OF THE MEASURED AMOUNT NORMALLY INJECTED. THE TECHNICIAN REPLACED THE SV4 VALVE, PERFORMED A TEST CYCLE AND CONFIRMED THE UNIT WAS OPERATING TO SPECIFICATION. THE UNIT WAS INSTALLED IN (B)(6) 2013 AND IS CURRENTLY UNDER STERIS WARRANTY.

Description of Event or Problem · 1

THE USER FACILITY REPORTED SEVERAL STAFF MEMBERS IN THE DEPARTMENT WERE EXPOSED TO HYDROGEN PEROXIDE VAPOR. THE EMPLOYEES WERE STANDING CLOSE TO THE V-PRO 1 PLUS STERILIZER AND EXPERIENCED BURNING EYES AND THROATS FOLLOWING A CANCELLED CYCLE. THE FACILITY EVACUATED THE ROOM FOR APPROXIMATELY ONE HOUR AND HAD THE MACHINE SHUT DOWN PENDING INSPECTION BY STERIS SERVICE. NO PROCEDURAL DELAYS/CANCELLATIONS WERE REPORTED.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
290887	V-PRO 1 PLUS STERILIZER	STERILIZER	MLR	STERIS MEXICO, S. DE R.L. DE C.V.

Patients

Seq	Age	Sex	Outcome	Treatment
1