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

Catalog Number 05342716001

Device Problem Complete Blockage (1094)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/08/2020

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.(b)(4).

Event Description

A us customer alleged that the benchmark ultra stainer module waste filter was clogged resulting in a waste tub overflow, with liquid reaching the floor.The tub sensors did not properly report the error to prevent fluid leakage.It was indicated that a fields service engineer (fse) was dispatched and waste filter was cleaned.No harm or injury occurred as a result of the liquid on the floor.

• 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 drive; na; tuscon, AZ 85755 ; 9082537112
• MDR Report Key: 9635645
• MDR Text Key: 198726055
• Report Number: 2028492-2020-00001
• 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: 01/27/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/28/2020
• 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: 01/08/2020
• 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
• Type of Device Usage: N
• Patient Sequence Number: 1