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

Catalog Number 05342716001

Device Problems Complete Blockage (1094); Fluid/Blood Leak (1250)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 03/04/2020

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 upgrade has not been performed in this instrument to date.(b)(4).

Event Description

The us customer alleged that the waste tub of benchmark ultra stainer overflowed during a decontamination procedure.The waste fluid reached the floor.The field service engineer (fsc) found that a clogged waste filter, clogged waste tubing, and clogged waste junction caused the overflow.The tub sensors did not properly report the error to prevent fluid leakage.The fse cleaned every item and left the instrument operational.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 dr; na; tuscon, AZ 85755 ; 9082537112
• MDR Report Key: 9872161
• MDR Text Key: 194781110
• Report Number: 2028492-2020-00004
• 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: 03/24/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/24/2020
• 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: 03/04/2020
• 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