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

Catalog Number	06917259001
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/31/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
An investigation has been initiated and is on-going.A follow-up report will be submitted upon the completion of the investigation.(b)(4).
Event or Problem Description
A customer from the united states reported that their he 600 system experienced fluid overflow in the middle staining module and fluid was seen coming out from where the cartridges load for the coverslip module.No alleged harm or injury.
Additional Manufacturer Narrative
Roche has confirmed complaints regarding fluid leaks within the middle stainer module of the ventana he 600 that likely resulted in electrical shorts at the plate heater connections that then escalated into fires.In the cases, the fire originated from the middle stainer modules at the backside of the connectors for the plate heaters.A third party fire analysis investigation was conducted for the cases and a capa has been initiated.Because the fire and any associated smoke could extend beyond the instrument, there is a risk of injury, potentially serious, from smoke inhalation and/or direct contact with the fire itself.Routine fire/smoke safety and evacuation procedures mitigate the risk of injury.Additionally, given the ability to retest the patient sample, the probability that this failure mode would result in adverse health consequences for patients is estimated as very low.No injuries have been reported to date.Consignees have been notified to not leave the instrument unattended when the power is on.Consignees were also instructed not to place the system in standby mode overnight when unattended until further mitigation actions have been implemented and to please turn off the power of the instrument when it is unattended.A stainer temperature monitoring update will be implemented and plate heater connectors will be coated with liquid electrical tape (let).These actions mitigate the risk by monitoring the temperature and by protecting the sources from leaks and subsequently a short circuit, which would prevent the possibility of heat generation.Both stainer temperature monitoring and liquid electrical tape updates are already implemented in the field in the us.An additional software update (v1.10.2 software release) to turn off the power to the stainer was made available on 14-oct-2022 and is scheduled to be installed on all instruments in the field by 14-oct-2023.This feature powers off the stainer whenever an excessive heater temperature is detected by the system.Component code as well as the eval result and conclusion codes were added.

• Brand Name: VENTANA HE 600 SYSTEM
• Common Device Name: SLIDE STAINER, AUTOMATED
• Manufacturer (Section D): VENTANA MEDICAL SYSTEMS INC; 1910 e innovation park dr; tuscon AZ 85755
• Manufacturer Contact: stacie-ann creighton ; 1910 east innovation park dr; na; tuscon, AZ 85755 ; 9082537112
• MDR Report Key: 14801769
• Report Number: 2028492-2022-00004
• Device Sequence Number: 17354575
• Product Code: KPA
• UDI-Device Identifier: 04015630976010
• UDI-Public: 04015630976010
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: 510K EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Remedial Action: Notification,Recall
• Type of Report: Initial,Followup
• Report Date (Section B): 11/11/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 06917259001
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/31/2022
• Supplement Date Received by Manufacturer: 10/26/2022
• Initial Report FDA Received Date: 06/24/2022
• Supplement Report FDA Received Date: 11/11/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: 2028492-06-01-2022-002-C
• Patient Sequence Number: 1
• Patient Sex: Unknown