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

Catalog Number 06917259001

Device Problems Circuit Failure (1089); Leak/Splash (1354)

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

Event Date 04/16/2021

Event Type  malfunction  

Manufacturer Narrative

The device has been requested back for evaluation.An investigation to evaluate the customer issue is ongoing.(b)(4).

Event Description

A customer from the (b)(6) reported that their he 600 system experienced an instrument leak along accompanied with a tub overflow alarm; most likely resulting in an electric short.The instrument made a sound and a localized smoke was noticed.The smoke was contained within the instrument and the situation did not trigger any smoke alarm or laboratory evacuations.No alleged harm or injury.

Manufacturer Narrative

Per additional information, the customer issue was resolved by replacement of the stainer module by field service engineer, at the customer site.The instrument was returned to routine operation.The affected stainer module was returned for investigation.It was determined that there was sufficient evidence to substantiate the allegation of shorting within the instrument.Visual and surface inspection showed no obvious area for leaks within the tubing after the stainer had been removed from the instrument.The shorting was contained within the device.(b)(4).

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.Changed device code from circuit failure to leak/splash.

• 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
• Manufacturer Contact: stacie-ann creighton ; 1910 east innovation park dr; na; tuscon, AZ 85755 ; 9082537112
• MDR Report Key: 11846467
• MDR Text Key: 252244080
• Report Number: 2028492-2021-00005
• Device Sequence Number: 1
• Product Code: KPA
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: 510K EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional
• Reporter Occupation: Other Health Care Professional
• Remedial Action: Notification
• Type of Report: Initial,Followup,Followup
• Report Date: 06/24/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/18/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 06917259001
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/01/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: 2028492-06-01-2022-002-C
• Patient Sequence Number: 1