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

Catalog Number 05342716001

Device Problems Device Alarm System (1012); Loss of Power (1475); Smoking (1585)

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

Event Date 08/30/2019

Event Type  malfunction  

Manufacturer Narrative

During the visit from the local field service engineer, it was indicated that the air filter tubing going to the waste manifold fitting broke, causing fluid to pour onto the power plug causing to short.The customer site did not want the instrument replaced; as such, parts were removed and exchanged.After the replacement of parts, the local field service engineer performed an operational qualification run on the instrument.The instrument is now performing within acceptable operating specifications.(b)(4).

Event Description

A us customer stated that there was smoke coming from the benchmark ultra stainer module, and there was no alarm or error generated.The customer indicated that the instrument automatically shut off.The operator left the lab temporarily because of the quantity of smoke.There was no harm or injury indicated, and lab operator did not seek any medical attention.A local field service engineer was dispatched to the customer site.

Manufacturer Narrative

The initial root cause investigation noted signs of fluid leaks.For the instrument serial number (b)(4) associated with this case, a tub connection failure resulted in waste emptying into the bottom of the instrument.The waste fluid 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 leak.(b)(4).

Manufacturer Narrative

In the case, the primary leak sources 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).

• Brand Name: BENCHMARK ULTRA STAINER MODULE
• Type of Device: SLIDE STAINER, AUTOMATED
• Manufacturer (Section D): VENTANA MEDICAL SYSTEMS; 1910 e. innovation park dr.; tucson AZ 85755
• MDR Report Key: 9120312
• MDR Text Key: 165643668
• Report Number: 2028492-2019-00019
• 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: 09/25/2019
• 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