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

Catalog Number 05342716001

Device Problems Fluid/Blood Leak (1250); Fracture (1260); Mechanical Problem (1384)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/14/2021

Event Type  malfunction  

Manufacturer Narrative

It was noted that an o-ring broke, and had been discarded; this was reported to be the source of the alleged leak.The instrument is now operational.Capa investigations have been conducted to identify the root cause for these events.The root cause specific to the electrical aspects of the benchmark ultra instrument are completed.The investigation identified there was a fluid leak that resulted in fluids getting inside the power cord connector to the instrument.Once inside the connector, the fluid created an electrical connection between the terminals within the ac power receptacle, which over time caused the external power connector to burn.The investigation regarding the cause of the fluid leak indicates the potential for certain tube fittings to fracture or break, which may lead to a leak.The root cause report identified several contributing factors, including but not limited to the impact of material compatibility on potential leak sources and implementation of several categories of suboptimal leak mitigation measures within the instrument.Consignees were notified.Local field service engineers will perform specific service actions, including the installation of a power connector shield, which will prevent fluid entry into the power cord connection and socket, inspection of specific instrument parts for signs of cracks and fluid leaks, and completion of the waste tub and filter upgrade, if needed.(b)(4).

Event Description

A customer in china reported to observe liquid leaking from the benchmark ultra instrument and evidence of a heat event on the emi filter.The instrument shut off by itself.There was no lab evacuations and no report of harm or injury to the laboratory personnel.

• 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: 11301106
• MDR Text Key: 231115778
• Report Number: 2028492-2021-00002
• Device Sequence Number: 1
• Product Code: KPA
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: 510K EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 02/09/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/09/2021
• 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: 01/14/2021
• 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
• Removal/Correction Number: 2028492-2019-00019
• Patient Sequence Number: 1