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

Model Number XN-10

Device Problem Leak/Splash (1354)

Patient Problems Exposure to Body Fluids (1745); Unspecified Eye / Vision Problem (4471)

Event Date 03/17/2021

Event Type  Injury  

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 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
• Type of Device: AUTOMATED HEMATOLOGY ANALYZER
• Manufacturer (Section D): SYSMEX CORPORATION, I SQUARE; 262-11 mizuashi; noguchi-cho; kakogawa-city, hyogo 675-0 019; JA 675-0019
• Manufacturer (Section G): SYSMEX CORPORATION, I SQUARE; 262-11 mizuashi; noguchi-cho; kakogawa-city, hyogo 675-0 019; JA 675-0019
• Manufacturer Contact: nancy gould ; 577 aptakisic rd; lincolnshire, IL 60069 ; 2245439678
• MDR Report Key: 11575783
• MDR Text Key: 243121239
• Report Number: 1000515253-2021-00004
• Device Sequence Number: 1
• Product Code: GKZ
• UDI-Device Identifier: 04987562424214
• UDI-Public: (01)04987562424214(11)200402
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K112605
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 03/26/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/26/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: XN-10
• Device Catalogue Number: AP795756
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/18/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/01/2020
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention