MAUDE Adverse Event Report: SYSMEX CORPORATION, I SQUARE XN-10; AUTOMATED HEMATOLOGY ANALYZER

Model Number	XN-10
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Codes	Exposure to Body Fluids (1745); Unspecified Eye / Vision Problem (4471)
Date of Event	03/17/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The user was wearing a lab coat and gloves at the time of the incident.The sysmex xn-3000 instructions for use (ifu), chapter 2 - safety information, section 2.4 - avoiding infections, states, "when performing any task on the instrument, such as testing, maintenance, preparation, or post processing, be sure to wear adequate personal protective equipment, such as protective gloves, a protective mask, protective eyewear, and a lab coat." the user was not wearing safety glasses.Section 2.4 goes on further stating users are to connect waste tubing to a waste fluid tank or other dedicated waste receptacle.To avoid the risk of waste spillage, users are advised to secure waste tubing in place and regularly verify waste tubing remains properly secured.Waste tubing and drain maintenance is the responsibility of the laboratory.Waste tubing was not properly secured in the drain.A sysmex service engineer (se) was dispatched.The se inserted all waste tubing directly into the floor drain and secured all tubing to prevent recurrence.No systemic product deficiency was identified.
Event or Problem Description
While investigating an analyzer leak during operation, the user observed waste tubing was not securely inserted into the drain causing waste to splash into the user's eyes.The user's eyes were immediately flushed by the laboratory's eyewash station, and the user sought medical attention from an exposure nurse.The user was placed on the (b)(6) protocol, which included testing and the administration of the prophylactics isentress and truvada.The user suffered eye irritation from the waste splash and/or the eyewash, as well as nausea, vertigo, and vomiting from the prophylactics.It is unknown if the user sought medical care for the eye irritation.

• Brand Name: XN-10
• Common Device Name: AUTOMATED HEMATOLOGY ANALYZER
• Manufacturer (Section D): SYSMEX CORPORATION, I SQUARE; 262-11 mizuashi; noguchi-cho; kakogawa-city, hyogo 675-0 019; JA 675-0019
• MDR Report Key: 11575783
• Report Number: 1000515253-2021-00004
• Device Sequence Number: 19947116
• Product Code: GKZ
• UDI-Device Identifier: 04987562424214
• UDI-Public: (01)04987562424214(11)200402
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K112605
• 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
• Type of Report: Initial
• Report Date (Section B): 03/26/2021

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: XN-10
• Device Catalogue Number: AP795756
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/18/2021
• Initial Report FDA Received Date: 03/26/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention