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

Catalog Number 05342716001

Device Problem Mechanical Problem (1384)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/23/2020

Event Type  malfunction  

Manufacturer Narrative

The following failure mode is the same event reported in mdr-2028492-2016-00004-00, which caused serious slip, and fall injury.A new waste tub and filter kit have been released to increase the reliability of the waste system.This is achieved by increasing the holding capacity of the waste tub and removing the inline waste filter.A new customer cleanable waste strainer has been created and added to the waste tub.This upgrade has not yet been performed at the customer site.(b)(4).

Event Description

A customer in the us reported that their benchmark ultra instrument would not start due to fluid inside the instrument.The fluid was observed under and inside the instrument and waste tubs after an overnight run had been stopped.The laboratory operator confirmed there have been no slips or falls while working with the instrument and the fluid has been cleaned up.A field service engineer was dispatched to the site and confirmed the fluid in tub exceeded maximum and fluid reached the floor.The field service engineer replaced many instrument parts and performed an operational qualification.All tests and verification passed.

• 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
• Manufacturer Contact: stacie-ann creighton ; 1910 e innovation park dr; na; tuscon, AZ 85755 ; 9082537112
• MDR Report Key: 10848227
• MDR Text Key: 216629720
• Report Number: 2028492-2020-00011
• 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
• Type of Report: Initial
• Report Date: 11/16/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/16/2020
• 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: 10/23/2020
• 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
• Patient Sequence Number: 1