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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: VENTANA MEDICAL SYSTEMS, INC. BENCHMARK ULTRA; SLIDE STAINER, AUTOMATED
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VENTANA MEDICAL SYSTEMS, INC. BENCHMARK ULTRA; SLIDE STAINER, AUTOMATED Back to Search Results
Catalog Number 05342716001
Device Problem Mechanical Problem (1384)
Patient Problems Burn(s) (1757); Respiratory Distress (2045); No Consequences Or Impact To Patient (2199)
Event Date 09/15/2020
Event Type  malfunction  
Manufacturer Narrative
A field service engineer visited the site and indicated that the fluidic leakage came from the option tubing or option reservoir of the instrument.The fse confirmed that multiple electronics parts including the transformer had developed crystallization, meaning the fluidic leakage was likely the direct cause of the electrical short.The investigation is on-going.A supplemental report will be submitted when conclusions become available.(b)(4).
 
Event Description
An (b)(6) customer reported they found liquid leaking from their benchmark ultra instrument.The liquid was located on the floor.Additionally, it was reported that the instrument turned off.There were no laboratory evacuations and the operator was not affected.The instrument was installed back in 2010 and has since been replaced.
 
Manufacturer Narrative
Capa investigations have been conducted.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.The root cause report 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).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).
 
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Brand Name
BENCHMARK ULTRA
Type of Device
SLIDE STAINER, AUTOMATED
Manufacturer (Section D)
VENTANA MEDICAL SYSTEMS, INC.
1910 e innovation park dr
tucson AZ 85755
MDR Report Key10677293
MDR Text Key211280688
Report Number2028492-2020-00009
Device Sequence Number1
Product Code KPA
Combination Product (y/n)N
PMA/PMN Number
510K EXEMPT
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,health professional
Remedial Action Notification
Type of Report Initial,Followup
Report Date 12/17/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/14/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue Number05342716001
Date Manufacturer Received12/14/2020
Is This a Reprocessed and Reused Single-Use Device? No
Removal/Correction Number2028492-08-18-2020-001-C
Patient Sequence Number1
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