MAUDE Adverse Event Report: BECKMAN COULTER IRELAND INC AQUIOS CL FLOW CYTOMETER; FLOW CYTOMETRIC REAGENTS AND ACCESSORIES.

Model Number	TN AQUIOS CL
Medical Device Problem Code	Mechanical Problem (1384)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/12/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Onsite service was scheduled.The field service engineer (fse) confirmed the issue upon inspection of the instrument.To resolve the issue the fse replaced the sample piercing probe, syringe pump, smart motor, syringe pump, and sheath damper.The fse also performed smart motor programing and flow cell bleaching procedures to complete service and optimize instrument function.Bec internal identifier - (b)(4).
Event or Problem Description
The customer reported a delay of results for cd34+ on one patient due to destruction of the specimen when their aquios cl flow cytometer crashed because of a motion communication failure.The specimen had to be redrawn causing a delay of results.No erroneous results were generated.There were no reports of serious harm to patient or operator.

• Brand Name: AQUIOS CL FLOW CYTOMETER
• Common Device Name: FLOW CYTOMETRIC REAGENTS AND ACCESSORIES.
• Manufacturer (Section D): BECKMAN COULTER IRELAND INC; lismeehan; o callaghans mills clare ; EI
• Manufacturer (Section G): BECKMAN COULTER, INC.; 11800 sw 147th ave; miami FL 33196
• Manufacturer Contact: angela vettel ; 250 s kraemer blvd; brea, CA 92821 ; 7149613625
• MDR Report Key: 22440841
• Report Number: 1061932-2025-00025
• Device Sequence Number: 16934838
• Product Code: OYE
• UDI-Device Identifier: 15099590225889
• UDI-Public: (01)15099590225889(11)170728
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K141932
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 07/08/2025

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: TN AQUIOS CL
• Device Catalogue Number: 830166
• 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: 06/12/2025
• Initial Report FDA Received Date: 07/08/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 07/28/2017
• 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
• Patient Sex: Unknown