MAUDE Adverse Event Report: ULTRA CLEAN SYSTEMS, INC. TRITON 36 ULTRASONIC WASHER; CLEANER, ULTRASONIC, MEDICAL INSTRUMENT

Catalog Number 6003000804

Device Problems Device Reprocessing Problem (1091); False Positive Result (1227); Product Quality Problem (1506)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 12/05/2022

Event Type  malfunction  

Event Description

Getinge/ultraclean triton 36 ultrasonic washer/disinfector fails to pass efficacy testing when properly dosed with the getinge powercon triple enzyme detergent as advised by getinge technical support.The dosing ratio advised is between 1/12oz to 1/2oz per gallon.Testing conducted using the maximum dosing of 1/2oz per gallon.Triton was verified to be fully operation and free of any debris during all testing which was performed only with empty loads.Since acquiring the triton, the top unit of this washer has never passed efficacy testing and the manufacturer informed us that this was due to our facility failing to use their testing product, wash-checks-u.However, even while using their product (wash-checks-u), the top level has always been problematic as it's the farthest level from the ultrasonic generator in the unit.Our facility made this decision to only use the sonocheck after in-house testing, as wash-checks-u was found to be a very ineffective testing supply as it would pass when rinsed under running water, not requiring any cavitation thus providing a false positive result.Per a publication made by aami(association of the advancement of medical instrumentation), (http://www.Healthmark.Info/cleaningverification/sonocheck/sonic_article_aami_july_august_2019.Pdf) as well as our first-hand test, we changed our standard practice to use only sonocheck testing supplies to validate cavitation in our ultrasonic washers.Despite numerous efforts to have getinge service our machine, and after speaking to getinge support we were advised to discontinue using the top level and getinge insisted that this failure to use their product was the root cause of this failure.At this point, only the middle and bottom levels were used.Recently, the middle level has been causing us issues after less than 2 years of ownership.Getinge technicians were also on-site to help troubleshoot but were unsuccessful.Efficacy testing using healthmark sonocheck failed on both the top and middle levels.Only the bottom level passed.After this recent incident, we were advised to now only use the bottom level of this washer and were again asked to reach out to the manufacturer of sonocheck to inform them that their sonocheck product was ineffective.Based on the efficacy tests and sonocheck device, this sonic machine design doesn't have enough sonication power to reach every level when all lumen baskets are tested together.This is a safety issue as we depend on this machine to mechanically clean our robotic arms and other lumened items.

• Brand Name: TRITON 36 ULTRASONIC WASHER
• Type of Device: CLEANER, ULTRASONIC, MEDICAL INSTRUMENT
• Manufacturer (Section D): ULTRA CLEAN SYSTEMS, INC.
• MDR Report Key: 15940698
• MDR Text Key: 305244103
• Report Number: MW5113695
• Device Sequence Number: 1
• Product Code: FLG
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Unknown
• Type of Report: Initial
• Report Date: 12/05/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/07/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Catalogue Number: 6003000804
• Was Device Available for Evaluation?: Yes
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Sex: Prefer Not To Disclose