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

Model Number	AR310
Medical Device Problem Codes	Fluid/Blood Leak (1250); Mechanical Problem (1384)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	12/23/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
The united states of america customer reported "the artisan link pro failed to aspirate the waste fluids from the slide clips and wash basin at the end of the run.It appears that this occurred throughout the run as the drip pan was flooded.Although the lab has a second artisan, the slides cannot be repeated since these were kidney sections and the blocks cannot be recut.Patient impact is unknown.18 slides were impacted (3 cases of patient transplant kidney biopsies)".The field service engineer repaired the instrument by replacing the pump assembly and waste manifold which resolved this malfunction.It is unknown if testing was able to be completed and if the patient will need a re-biopsy.More than 3 good faith efforts were made to contact the customer with no answer to these issues.There was no direct or indirect user harm reported.
Additional Manufacturer Narrative
No erroneous staining result was reported by the customer in connection with this incident.No user harm was indicated.Patient impact is unknown at this time.Therefore, this report is being filed as part of agilent's commitment to due diligence reporting.Patient information has not been provided by the user.

• Brand Name: ARTISAN LINK PRO
• 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 (Section G): AGILENT TECHNOLOGIES SINGAPORE (INTL.) PTE LTD.; no.1 yishun avenue 7; singapore, north east 76892 3; SN 768923
• Manufacturer Contact: mary o'neill ; 1834 state highway 71 west; cedar creek, TX 78612 ; 3026338510
• MDR Report Key: 16240940
• Report Number: 3003423869-2023-00012
• Device Sequence Number: 6351955
• Product Code: KPA
• UDI-Device Identifier: 05700571108451
• UDI-Public: 05700571108451
• Combination Product (Y/N): N
• Initial Reporter State: IL
• 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): 01/25/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• 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: 12/27/2022
• Initial Report FDA Received Date: 01/25/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/01/2013
• 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: Unknown
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown