MAUDE Adverse Event Report: VENTANA MEDICAL SYSTEMS, INC. BENCHMARK XT; SLIDE STAINER, AUTOMATED

Catalog Number 05265231001

Device Problem Fluid/Blood Leak (1250)

Patient Problems No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 08/10/2020

Event Type  malfunction  

Manufacturer Narrative

Local fse replaced the damaged components and the instrument is running as intended.The affected parts were discarded at the customer site.The investigation is ongoing.(b)(4).

Event Description

An (b)(6) customer reported smoke and a burning smell coming from the benchmark xt instrument.The local field service engineer (fse) found that a fitting broke within the instrument, resulting in leaking liquids, which caused an electrical short.Consequently, the transformer burnt up.The customer opened the window and left the lab.There was no report of harm or injury.

Manufacturer Narrative

Investigation found a broken quick disconnect fitting allowed reagent leakage onto the power transformer.The power transformer experienced a temporary low current shorting due to reagent ingress which caused insulation charring/smoke which then later self-extinguished once the reagent evaporated.The system is (b)(4) certified.The (b)(4) certification evaluates materials of construction for flammability and provides independent assurance that any internal fire would not or would be unlikely to spread outside the instrument frame.Additionally, (b)(4) evaluates that thermal and electrical fuses cut power in runaway conditions.The capa investigation of the fluids leak has identified several contributing factors, including but not limited to the impact of material compatibility on potential leak sources and implementation of several categories of suboptimal leak mitigation measures within the instrument (for example, lack of hose clamps to keep fluidics tubing from separating from fittings).Improvements have been made to the ventana design process, including design readiness and material compatibility work instructions and checklists.(b)(4).

• Brand Name: BENCHMARK XT
• 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 dr; na; tuscon, AZ 85755 ; 9082537112
• MDR Report Key: 10495993
• MDR Text Key: 234270983
• Report Number: 2028492-2020-00008
• Device Sequence Number: 1
• Product Code: KPA
• Combination Product (y/n): N
• Reporter Country Code: IT
• 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
• Type of Report: Initial,Followup
• Report Date: 01/25/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/04/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 05265231001
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/15/2021
• 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
• Type of Device Usage: N
• Patient Sequence Number: 1