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

Model Number	XN-20
Medical Device Problem Codes	Thermal Decomposition of Device (1071); Charred (1086); Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	05/30/2018
Type of Reportable Event	Malfunction
Additional 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 or Problem 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.
Additional 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
• Common Device Name: 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
• Report Number: 1000515253-2018-00009
• Device Sequence Number: 1652310
• Product Code: GKZ
• UDI-Device Identifier: 04987562424221
• UDI-Public: (01)04987562424221
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K112605
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Medical Technologist
• Remedial Action: Replace
• Type of Report: Initial,Followup
• Report Date (Section B): 07/31/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Medical Technologist
• Device Model Number: XN-20
• Device Catalogue Number: AE797961
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 05/31/2018
• Supplement Date Received by Manufacturer: 07/27/2018
• Initial Report FDA Received Date: 06/28/2018
• Supplement Report FDA Received Date: 07/31/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1