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

Catalog Number 05342716001

Device Problem Fluid/Blood Leak (1250)

Patient Problem Fall (1848)

Event Date 08/22/2019

Event Type  malfunction  

Manufacturer Narrative

The local field service engineer cleaned the clogged waste filter; this service action remedied the customer's observation.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 customer in (b)(6) reported that their benchmark ultra stainer module leaked, and that the leakage reached the floor.No harm or injury occurred as a result of the leakage and fluid on the lab's floor.The following failure mode is same event reported in mdr-2028492-2016-00004-00, which caused a slip and fall injury.

• Brand Name: BENCHMARK ULTRA STAINER MODULE
• Type of Device: SLIDE STAINER, AUTOMATED
• Manufacturer (Section D): VENTANA MEDICAL SYSTEMS; 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: 9079129
• MDR Text Key: 202057517
• Report Number: 2028492-2019-00018
• 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
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 09/17/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/17/2019
• 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: 08/22/2019
• 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