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	Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/20/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
The customer reported that the aquios cl flow cytometer waste connector broke, resulting in a leakage of waste fluid.The operator was exposed to the leaked fluid while investigating the origin of the leak.The operator was wearing only gloves as personal protective equipment at the time of the event.While leaning into the instrument, the operator¿s mouth and eyes were exposed to the waste fluid.The operator sought medical attention and is receiving antiretroviral treatment for 28 days as a result of the event.Operators in this laboratory will now use a mask with a visor in addition to gloves while troubleshooting the instruments.There was no impact to patient or patient samples as a result of this event.
Additional Manufacturer Narrative
The assignable cause of the event is considered use error, the operator was not wearing the proper ppe while troubleshooting the instrument.Upon exposure, the operator discontinued troubleshooting the instrument.A beckman coulter field service engineer (fse) went to the customer site and replaced a broken waste connector that was causing the leak.Per the aquios instructions for use (pn: b21896): ¿ beckman coulter, inc.Urges its customers and employees to comply with all national health and safety standards such as the use of barrier protection.This may include, but is not limited to, protective eyewear, gloves, and suitable laboratory attire when operating or maintaining this or any other automated laboratory analyzer.Bec internal identifier case: (b)(4).

• 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 avenue; miami FL 33196 2031
• Manufacturer Contact: angela vettel ; 250 s. kraemer blvd.; brea, CA 92821 ; 7149613625
• MDR Report Key: 20185721
• Report Number: 1061932-2024-00012
• Device Sequence Number: 18318860
• Product Code: OYE
• UDI-Device Identifier: 15099590225889
• UDI-Public: (01)15099590225889(11)200302
• Combination Product (Y/N): N
• Initial Reporter Country: PO
• PMA/510(K) Number: K141932
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 09/10/2024

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: TN AQUIOS CL
• Device Catalogue Number: B30166
• Device Lot Number: N/A
• 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: 08/20/2024
• Initial Report FDA Received Date: 09/10/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/02/2020
• 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