MAUDE Adverse Event Report: VENTANA MEDICAL SYSTEMS INC BENCHMARK ULTRA STAINER MODULE; SLIDE STAINER, AUTOMATED

Catalog Number 05342716001

Device Problems Fire (1245); Smoking (1585); Electrical Shorting (2926)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 07/09/2019

Event Type  malfunction  

Manufacturer Narrative

After the incident, the local field service engineer (fse) checked the waste filter for leaks and found none, and there was no residual fluid in the instrument power plug either.When the fse placed the transformer on its side, it dampened the cloth it was sitting on, suggesting an instrument leak could have been a contributing factor to the reported fire.Investigation is ongoing.The affected parts and instrument are being requested to be returned for investigation.(b)(4).

Event Description

While at a us customer site, a local field service engineer reported smoke and flames coming from the benchmark ultra stainer module's power plug.The local fse was performing an operational qualification run when the instrument experienced an electrical short that damaged the instrument power plug, the emi filter, and transformer.The instrument had been powered for 40 minutes and was in the middle of ramping up heaters for a cleaning cycle.It was indicated to be an intense short, enough to create ash in the air and smoke.The customer site's circuit breaker tripped shortly afterward and stopped the power to the instrument.No fire extinguisher was used to smother the fire.The fse indicated this was a high arc event and was immediately dispersed when power was cut off by the breaker tripping.There situation did not lead to any laboratory evacuations and no one was harmed.

Manufacturer Narrative

In the case, the primary leak source originated from fluidic components and caused an electrical short circuit in the emi (electromagnetic interference) line filter leading to burning and melting of the electrical cord connector and socket.Through the extent of the investigation, it was determined that waste tub overflow events may also result in fluids migrating into the power socket.Capa investigations have been conducted to identify the root cause for these events.The root cause specific to the electrical aspects of the benchmark ultra instrument are completed.The investigation identified there was a fluid leak that resulted in fluids getting inside the power cord connector to the instrument.Once inside the connector, the fluid created an electrical connection between the terminals within the ac power receptacle, which over time caused the external power connector to burn.The investigation regarding the cause of the fluid leak indicates the potential for certain tube fittings to fracture or break, which may lead to a leak.Additional analysis and investigation is ongoing to determine the root cause(s) of fluid leaks.Consignees will be notified.Local field service engineers will perform specific service actions, including the installation of a power connector shield, which will prevent fluid entry into the power cord connection and socket, inspection of specific instrument parts for signs of cracks and fluid leaks, and completion of the waste tub and filter upgrade, if needed.(b)(4).

Manufacturer Narrative

The initial root cause investigation noted signs of fluid leaks.In reviewing the service history for the instrument serial number (b)(6) associated with this case, there was a failure of the 5 valve manifold and a waste tub overflow events, which resulted in fluids throughout the instrument.The fluids created an electrical short inside the power socket, which over time generated a large amount of heat, smoke and eventually burning and melting of the electrical cord connector and socket.A secondary cause for the electrical short was the lack of fluid ingress protection for the power cord socket from the backside of the instrument and a fluid path allowing for fluids inside the instrument to reach the backside where the power socket is located.A separate investigation is currently open to investigate and resolve the causes for the aforementioned leaks.(b)(6).

• Brand Name: BENCHMARK ULTRA STAINER MODULE
• Type of Device: SLIDE STAINER, AUTOMATED
• Manufacturer (Section D): VENTANA MEDICAL SYSTEMS INC; 1910 e innovation park dr; tucson AZ 85755
• MDR Report Key: 8871129
• MDR Text Key: 153837681
• Report Number: 2028492-2019-00013
• 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: 08/31/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/07/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 05342716001
• Date Manufacturer Received: 08/18/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: 2028492-08-18-2020-001-C
• Patient Sequence Number: 1