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

Model Number AR310

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

Patient Problem Insufficient Information (4580)

Event Date 12/23/2022

Event Type  Injury  

Event 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.

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
• Type of Device: 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
• MDR Text Key: 308092690
• Report Number: 3003423869-2023-00012
• Device Sequence Number: 1
• Product Code: KPA
• UDI-Device Identifier: 05700571108451
• UDI-Public: 05700571108451
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Other Health Care Professional
• Remedial Action: Repair
• Type of Report: Initial
• Report Date: 01/25/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/25/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: AR310
• Device Catalogue Number: AR31030
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/27/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/01/2013
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other