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

Model Number	XN-10
Medical Device Problem Codes	Fire (1245); Melted (1385); Smoking (1585)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	06/28/2018
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 cleaning of salt crystals procedure within the fca was not performed correctly.The salt crystals created a salt bridge that allowed electricity to flow in an alternate path causing nearby resin parts to ignite.Investigation has revealed that the translation of fca for fses in (b)(4) was incomplete, in that it did not include instructions for removal of salt crystals if present during the correction process.The fca has been corrected, and re-distributed to all fses in (b)(4).Additionally, a verification process has been instituted at s-corp, to ensure translations are accurate and reflect the manufacturer's instructions.
Event or Problem Description
A user in (b)(6) reported a burning odor and flames coming from inside the analyzer.The user unplugged the power cable and used a fire extinguisher.A field service engineer (fse) arrived on-site and discovered leakage from valve assembly 22.Initial assessment indicates that the fire occurred on valve assembly 19, which is below valve assembly 22.Diaphragms, wiring cords, and protective plastic sheets were damaged.

• Brand Name: XN-10
• 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: 7726867
• Report Number: 1000515253-2018-00011
• Device Sequence Number: 16392739
• Product Code: GKZ
• UDI-Device Identifier: 04987562424214
• UDI-Public: (01)04987562424214
• 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: Other Health Care Professional
• Remedial Action: Replace
• Type of Report: Initial,Followup
• Report Date (Section B): 07/27/2018

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: Health Professional
• Device Model Number: XN-10
• Device Catalogue Number: AP795756
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 06/28/2018
• Supplement Date Received by Manufacturer: 06/28/2018
• Initial Report FDA Received Date: 07/27/2018
• Supplement Report FDA Received Date: 07/27/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1