FDA Adverse Event Malfunction Summary report: N

TRITON 36 ULTRASONIC WASHER CLEANER, ULTRASONIC, MEDICAL INS

MDR report key: 16565309 · Received March 16, 2023

Report

Report Number
MW5115789
Event Type
Malfunction
Date Received
March 16, 2023
Date of Event
March 13, 2023
Report Date
March 14, 2023
Manufacturer
ULTRA CLEAN SYSTEMS, INC.
Product Code
FLG
Product Problem
Yes
Report Source
Voluntary report
Reporter Location
HI, US
Reporter Occupation
OTHER HEALTH CARE PROFESSIONAL
Health Professional
Yes

Narratives

Description of Event or Problem · 0

GETINGE/ULTRACLEAN TRITON 36 ULTRASONIC WASHER/DISINFECTOR FAILS TO PASS EFFICACY TESTING. THIS IS A FOLLOW-UP TO REPORT #MW5113695 FILED ON 12/05/2022. AFTER BEING REACHED OUT TO BY THE MANUFACTURER, ULTRACLEAN SYSTEMS, THEY PROVIDED ME A SAMPLE OF THEIR CHEMICAL AND ASKED ME TO USE THAT INSTEAD OF MY DETERGENT THAT WAS PROVIDED BY GETINGE (THE COMPANY SOURCED TO SERVICE THIS MACHINE). WE RAN 7 CONSECUTIVE TESTS AND RESULTS VARY BUT THERE WAS SOME CONSISTENCY. LOAD - HOSPITAL CYCLE (ELONGATED TO 15 MIN), NEW WATER AND DETERGENT (0.5OZ/GAL) ¿ EMPTY LOAD, BOTTOM BASKET ¿ FAIL, MIDDLE BASKET ¿ FAIL, TOP BASKET ¿ FAIL LOAD 2 ¿ HOSPITAL CYCLE (ELONGATED TO 15 MIN), NEW WATER AND DETERGENT (0.5OZ/GAL) ¿ EMPTY LOAD; ADJUSTMENTS FROM PREVIOUS CYCLE - NONE; BOTTOM BASKET ¿ FAIL, MIDDLE BASKET ¿ FAIL; TOP BASKET ¿ FAIL LOAD 3 ¿ HOSPITAL CYCLE (ELONGATED TO 15 MIN), RE-USED WATER & DETERGENT (0.9OZ/GAL) ¿ EMPTY LOAD; ADJUSTMENTS FROM PREVIOUS CYCLE ¿ RE-USED WATER AND INCREASED DOSING TO 0.9OZ/GAL; BOTTOM BASKET ¿ PASS, MIDDLE BASKET ¿ PASS; TOP BASKET ¿ PASS LOAD 4 ¿ HOSPITAL CYCLE (ELONGATED TO 15 MIN), NEW WATER AND DETERGENT (0.7OZ/GAL) ¿ EMPTY LOAD; ADJUSTMENTS FROM PREVIOUS CYCLE ¿ NEW WATER AND REDUCED DOSING TO 0.7OZ/GAL; BOTTOM BASKET ¿ FAIL (SOME COLOR CHANGE BUT NOT PASSING), MIDDLE BASKET ¿ FAIL; TOP BASKET ¿ FAIL LOAD 5 ¿ HOSPITAL CYCLE (ELONGATED TO 15 MIN), RE-USED WATER AND DETERGENT (0.7OZ/GAL) ¿ EMPTY LOAD; ADJUSTMENTS FROM PREVIOUS CYCLE ¿ RE-USED WATER, BOTTOM BASKET ¿ PASS, MIDDLE BASKET ¿ FAIL; TOP BASKET ¿ FAIL LOAD 6 ¿ HOSPITAL CYCLE (ELONGATED TO 15 MIN), NEW WATER AND DETERGENT (0.9OZ/GAL) ¿ EMPTY LOAD; ADJUSTMENTS FROM PREVIOUS CYCLE ¿ NEW WATER AND INCREASED DOSING TO 0.9OZ/GAL, BOTTOM BASKET ¿ PASS, MIDDLE BASKET ¿ FAIL, TOP BASKET ¿ FAIL LOAD 7 ¿ HOSPITAL CYCLE (ELONGATED TO 15 MIN), RE-USED WATER & DETERGENT (0.9OZ/GAL) ¿ EMPTY LOAD; ADJUSTMENTS FROM PREVIOUS CYCLE ¿ REUSED WATER, BOTTOM BASKET ¿ PASS, MIDDLE BASKET ¿ PASS, TOP BASKET ¿ PASS. IT SEEMS THAT EACH TIME THE UNIT FILLS WITH WATER, IT DOESN'T DEGAS DESPITE IT BEING ADVERTISED AS HAVING AN AUTOMATIC DEGASSING FUNCTION. ONLY AFTER REUSING THE SOLUTION IN THE WASHER WOULD SIGNIFICANT PASSING RESULTS OCCUR. WHILE LOOKING INTO THE WASHER WHILE IT WAS RUNNING, EACH TIME NEW WATER WAS FILLED, THERE WOULD BE BUBBLES RISING TO THE TOP OF THE BASIN (BASICALLY A DEGASSING PROCESS). HOWEVER, THE MANUFACTURER ADVERTISES THIS AUTOMATIC DEGASSING FEATURE SO WHEN NEW WATER IS ADDED THE CYCLE WOULD ALWAYS HAVE A FAILING RESULT. ALSO, TO ACHIEVE A PASSING RESULT, IT WAS REQUIRED TO HAVE THE DOSING ON THE UPPER END OF THE SPECTRUM AS RESULTS WERE BETTER WITH 0.7 - 0.9OZ/GALLON. HAVING IT AT 0.5OZ/GAL COMPLETELY FAILED.

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
11900 TRITON 36 ULTRASONIC WASHER CLEANER, ULTRASONIC, MEDICAL INS CLEANER, ULTRASONIC, MEDICAL INSTRUMENT FLG ULTRA CLEAN SYSTEMS, INC. TRITON 36

Patients

Seq Age Sex Outcome Treatment
1 Unknown