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

Catalog Number 05342716001

Device Problems Fire (1245); Leak/Splash (1354); Smoking (1585); Electrical Shorting (2926)

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

Event Date 03/03/2021

Event Type  malfunction  

Manufacturer Narrative

Investigation is on-going.A follow-up report will be submitted upon the completion of the investigation.(b)(4).

Event Description

While at a us customer site doing some troubleshooting activities, a local field service engineer (fse) reported the gpio pcb experienced an electrical short when the benchmark ultra instrument was powered on.The fse used a co2 extinguisher to contain the event and the customer site's response team came in response to the fire alarm.No evacuation was needed and the event was contained.No injury occurred.

Manufacturer Narrative

Initial reporter sent report to fda is updated to yes as fda notified roche that report mw5100101 was received through fda's medwatch program.(b)(4).

Manufacturer Narrative

The instrument was shipped back for investigation.Investigation on the returned instrument concluded that the j1 connector and plug of pcb gpio assembly svc, located on the back of the benchmark ultra instrument, was compromised by fluid that migrated down tubing or cabling.This caused an electrical short, igniting the connector and plug material.Capa has been initiated.(b)(4).

Manufacturer Narrative

Investigations have been conducted to identify the root cause for these events.The most probable root cause of the issue was determined to be a fluid leak wicking down the cable to the gpio¿s j1 connector causing a short between the 24v and ground connections.Although a small and limiting short occurred due to the j1 connector and plug of pcb gpio assembly svc being compromised by the fluid that migrated down instrument tubing or cabling, there was enough heat to melt the connector and plug material.The 24 vdc pin shorted out at low amperage for an extended time and lost material on the gpio circuit, leading to resistive arcs that were fueled by the leaking reagents.Additional analysis and investigation is ongoing to determine the root cause(s) of fluid leaks.Consignees will be notified.Local field service engineers will contact the customers and perform specific service actions during a site visit, such as, inspecting all devices for any signs of current and/or past fluid leaks, cracks, or clogging and clean & replace any gpio boards that have these signs.Additionally, the field service engineers will rearrange cables that plug into port j1 of the left as well as right gpio boards of the instruments, to introduce a drip loop to each cable in order to redirect fluids away from the boards at j1 position, to help mitigate the issue.(b)(4).

• 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
• Manufacturer Contact: stacie-ann creighton ; 1910 e. innovation park drive; na; tuscon, AZ 85755 ; 9082537112
• MDR Report Key: 11580927
• MDR Text Key: 243921690
• Report Number: 2028492-2021-00003
• Device Sequence Number: 1
• Product Code: KPA
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: 510K EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Other Health Care Professional
• Remedial Action: Recall
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 01/26/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/29/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 05342716001
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/22/2021
• 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: 2028492-01-10-2022-001-C
• Patient Sequence Number: 1