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

Catalog Number 05265231001

Device Problem Fluid/Blood Leak (1250)

Patient Problems Fall (1848); Injury (2348)

Event Date 08/13/2019

Event Type  Injury  

Manufacturer Narrative

No additional updates have been provided relating to the injuries sustained or treatment received.The waste container was discarded at the customer site and is not available for further investigation.The age of the waste container is not known, but believed to be old and from the time of the instrument installation at the site (nov 2011).(b)(4).

Event Description

A customer in the (b)(6) reported their benchmark xt system waste container leaked, allowing liquid to reach the floor.A laboratory operator at the site slipped due to the leakage and fell on their back.As a result, the operator is receiving physical therapy due to the slip and fall.No medical report will be made available for the operator.

• Brand Name: BENCHMARK XT MODULE
• 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: 8960940
• MDR Text Key: 156781839
• Report Number: 2028492-2019-00015
• Device Sequence Number: 1
• Product Code: KPA
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: 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: 09/04/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/04/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 05265231001
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/14/2019
• 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
• Patient Outcome(s): Required Intervention