MAUDE Adverse Event Report: SYSMEX CORP. SYSMEX XN-10; AUTOMATED HEMATOLOGY ANALYZER

Model Number XN-10

Device Problem Human-Device Interface Problem (2949)

Patient Problem Laceration(s) (1946)

Event Type  Other  

Event Description

The user an xn-2000 configuration (s/n (b)(4) consisting of an xn-10 automated hematology analyzer (s/n (b)(4) ) together with an ru-20 reagent management system (s/n (b)(4) ) contacted the sysmex technical assistance center (tac) on (b)(6) 2014 regarding a user safety issue.The operator switched from using cellpack dst a concentrated reagent that is reconstituted by the ru-20 and seated inside of the conveyer, to non-concentrate, cellpack dcl to bypass the ru-20.The ru-20 is an accessory to the xn-2000 system.The user stated the way the tubing was run it required the box of regent to sit on the floor outside of the cabinet.Whether the tubing length or location of th exn-10 to which it was attached required the reagent box to be outside of the cabinet is unknown, but the cabinet door remained open.An operator on the night shift cut his leg on the open cabinet door requiring stitches.The user reported the incident and received medical attention in the emergency room.The dat the incident occurred in unknown.

Manufacturer Narrative

The xn-2000 instructions for use (ifu) states in a dedicated wagon (cabinet) the reagent for the analyzer is stored in a n area below.It states to open and close the reagent storage area below.It states to open and close the reagent storage area using handle on the dedicated wagon slowly, as the dedicated wagon is carrying reagent that is very heavy.After changing reagent close the reagent storage cabinet slowly with care.In this event the operator left the reagent on the floor with the cabinet door open.Good laboratory practices would indicate using safety measures recommended by the occupational safety and health (osha) to keep working and walking areas free of obstruction to prevent accidental user injury.The employer is responsible for assessing risk and providing adequate training and engineering controls for all reagents and other materials used in a laboratory.A laboratory associate confirmed the operator was sent to the emergency room from treatment immediately after the incident.The operator received stitches which were removed recently and is healing.This incident will be reported as the operator's injury required stitches to close the wound and stop bleeding.

• Brand Name: SYSMEX XN-10
• Type of Device: AUTOMATED HEMATOLOGY ANALYZER
• Manufacturer (Section D): SYSMEX CORP.; kakogawa ; JA
• Manufacturer (Section G): SYSMEX CORP.; 314-2 kitano, noguchicho; kakogawa ; JA
• Manufacturer Contact: peter shearstone, vp ; 577 aptakisic rd; lincolnshire, IL 60069-0000 ; 2245439514
• MDR Report Key: 3978801
• MDR Text Key: 4821120
• Report Number: 3009711478-2014-00017
• Device Sequence Number: 1
• Product Code: GKZ
• 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,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 06/03/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/01/2014
• 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: 06/03/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/01/2013
• Is the Device Single Use?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Other