MAUDE Adverse Event Report: SYSMEX CORPORATION XN-20; AUTOMATED HEMATOLOGY ANALYZER

Model Number XN-20

Device Problems Thermal Decomposition of Device (1071); Charred (1086); Fluid/Blood Leak (1250)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/30/2018

Event Type  malfunction  

Manufacturer Narrative

Sysmex corporation (b)(4) (s-corp) initiated a field corrective action (fca) after a similar event occurred in 2016.This was done as a countermeasure to prevent potential electrical damage due to fluid leakage.The fca includes rearrangement of wiring cords and placement of waterproof sheets over valve assemblies.Sysmex (b)(4) (sch) performed the fca at this facility.After investigation by s-corp, it was confirmed that the following within the fca was performed incorrectly: protective sheets were not applied to all areas, protective sheets were not secured in position, the wiring within the xn-20 was not rerouted according to instruction.Investigation regarding root cause determination continues.

Event Description

A user in (b)(6) reported a burning odor coming from inside the analyzer.A field service engineer (fse) arrived on-site and discovered leakage from a broken nipple on master valve 84 which is located in the valve assembly 22.The tubing connected to the broken nipple caused leaking onto valve assembly 19.The fluid from the leakage had dried over time, leaving salt residue in the area.On valve assembly 19, the fse also discovered the protective plastic sheet and wires were melted and charred.No harm or injury to operator was reported.

Manufacturer Narrative

Investigation has revealed that the translation of the field corrective action (fca) for field service engineers (fses) in china was incomplete, in that it did not include instructions for placement and securing of waterproof protective sheets during the correction process.The fca has been corrected and re-distributed to all fses in china.Additionally, a verification process has been instituted by sysmex corporation japan (s-corp), to ensure translations are accurate and reflect the manufacturer's instructions.

• Brand Name: XN-20
• Type of Device: AUTOMATED HEMATOLOGY ANALYZER
• Manufacturer (Section D): SYSMEX CORPORATION; 314-2 kitano; noguchi-cho; kakogawa, hyogo 675-0 011; JA 675-0011
• MDR Report Key: 7647958
• MDR Text Key: 112901340
• Report Number: 1000515253-2018-00009
• Device Sequence Number: 1
• Product Code: GKZ
• UDI-Device Identifier: 04987562424221
• UDI-Public: (01)04987562424221
• Combination Product (y/n): N
• PMA/PMN Number: K112605
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Remedial Action: Replace
• Type of Report: Initial,Followup
• Report Date: 07/31/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/28/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Medical Technologist
• Device Model Number: XN-20
• Device Catalogue Number: AE797961
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 07/27/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1