MAUDE Adverse Event Report: AGILENT TECHNOLOGIES SINGAPORE (INTL.) PTE LTD. ARTISAN LINK PRO SPECIAL STAINING SYSTEM; AUTOMATED SLIDE STAINER

Model Number	AR310
Medical Device Problem Codes	Device Remains Activated (1525); Excessive Heating (4030)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/26/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
While there was no direct, or indirect, user harm reported for this event; it is being reported due to the potential for harm if the event were to reoccur.
Event or Problem Description
The customer contacted an agilent field service engineer (fse) and reported that heater plate positions 41-48 appear to remain heated after the run has completed.Fse inspected the instrument and found that the vacuum pump was inoperable causing no reagent aspiration during a staining run.This caused the instrument to leak over multiple heater boards and heater plates resulting in heater 41-48 to remain active post staining run.Fse replaced the affected heater boards and heater plates.The instrument has been repaired, it is fully operational and is available to the user.No user harm was indicated.The customer was able to complete staining without delay.

• Brand Name: ARTISAN LINK PRO SPECIAL STAINING SYSTEM
• Common Device Name: AUTOMATED SLIDE STAINER
• Manufacturer (Section D): AGILENT TECHNOLOGIES SINGAPORE (INTL.) PTE LTD.; no.1 yishun avenue 7; singapore north east, sgp 76892 3; SN 768923
• Manufacturer Contact: angela bandy ; 1834 state highway 71 west; cedar creek, TX 78612 ; 3026338121
• MDR Report Key: 21228756
• Report Number: 3003423869-2025-00002
• Device Sequence Number: 15343338
• Product Code: KPA
• UDI-Device Identifier: 05700571108451
• UDI-Public: (01)05700571108451(11)180423
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Remedial Action: Repair
• Type of Report: Initial
• Report Date (Section B): 01/24/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: AR310
• Device Catalogue Number: AR31030
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/26/2024
• Initial Report FDA Received Date: 01/24/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/23/2018
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown