MAUDE Adverse Event Report: VENTANA MEDICAL SYSTEMS INC VENTANA HE 600 SYSTEM; SLIDE STAINER, AUTOMATED

Catalog Number 06917259001

Device Problems Thermal Decomposition of Device (1071); Melted (1385); Smoking (1585); Electrical Shorting (2926)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 07/17/2019

Event Type  malfunction  

Manufacturer Narrative

Capa has been initiated for the issue and root cause investigation is ongoing.Corrective and preventive measures will be implemented, as appropriate.(b)(4).

Event Description

A customer from (b)(6) reported that their he 600 system experienced an electrical short that led to burning and melting of components within the cover slipper module of the instrument.The burning and melting was described as localized and most of the smoke production was contained within the instrument.This situation did not trigger the building smoke alarm or lead to any laboratory evacuations and no one was harmed or injured.

Manufacturer Narrative

The root cause investigation, including the cause for the cleaning solution leak, is ongoing and suggests the cause of the event has multiple contributing factors, including the 65 micron filter and the stainer exchange value assembly in the cleaning solution fluidics line.At affected customer sites, roche local field service representatives will remove the cable that conducts electricity to the coverslipper module led pcba, proactively replace the stainer exchange valves, and proactively replace the 65 micron filters in the cleaning solution fluidics line.Site visits will be scheduled as appropriate.Capa has been initiated for the issue and root cause investigation is ongoing.Corrective and preventive measures will be implemented, as appropriate.(b)(4).

Manufacturer Narrative

The root cause investigation specific to the electrical aspects of the he 600 instrument has been completed.The burnt csm on the he 600 instrument was caused by the generation of sparks from the j1 connector on the csm led pcba, which ignited the delrin (plastic) manifold bracket.The sparking on the j1 connector was caused by acs fluid getting inside the j1 connector.The design of the delrin block contributes to acs fluid getting into the connector due to a channel that the cable rests, which acts to direct fluids towards the connector, once fluid enters the channel.The source for the acs leak was the 65 um filter used in the acs line.The root cause investigation specific to the systemic fluid path design leading to fluid leaks is completed and has concluded the issue is related to material incompatibility and supplier-related manufacturing defects with the 65 um filter.The supplier has improved their manufacturing and verification processes in relation to the 65um filter.Additionally, in jan-2020, manufacturing instructions were updated to release he600 instruments with the cable removed.In sep-2020, a new exchange valve polypropylene tee fitting was released with instructions for field service engineers to replace the fitting on all 3 stainers for all existing and new installations.Through the capa investigation, improvements have been made to the ventana design process, including design readiness and material compatibility work instructions and checklists.(b)(4).

• Brand Name: VENTANA HE 600 SYSTEM
• Type of Device: SLIDE STAINER, AUTOMATED
• Manufacturer (Section D): VENTANA MEDICAL SYSTEMS INC; 1910 e innovation park dr; tucson AZ 85755
• MDR Report Key: 8899541
• MDR Text Key: 154755863
• Report Number: 2028492-2019-00014
• Device Sequence Number: 1
• Product Code: KPA
• Combination Product (y/n): N
• PMA/PMN Number: 510K EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Remedial Action: Notification
• Type of Report: Initial,Followup,Followup
• Report Date: 01/11/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/15/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 06917259001
• Date Manufacturer Received: 12/14/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: 2028492-10-04-2019-001-C
• Patient Sequence Number: 1