inforMED
MalfunctionOYE

AQUIOS CL FLOW CYTOMETER

Received Jul 8, 2025 · Event occurred Jun 12, 2025

Report 1061932-2025-00025 · MDR key 22440841

Device

Generic name

Flow Cytometric Reagents And Accessories.

Model number

TN AQUIOS CL

Catalog number

830166

Product problems

  • Mechanical Problem
  • Mechanical Problem

Patient

NA · Unknown

  • No Clinical Signs, Symptoms or Conditions
  • No Clinical Signs, Symptoms or Conditions

Narrative

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).

Description of Event or Problem

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.