MAUDE Adverse Event Report: SYSMEX CORPORATION, I SQUARE SYSMEX CS-2100I AUTOMATED COAGULATION ANALYZER

Model Number	CS-2100I
Medical Device Problem Codes	Thermal Decomposition of Device (1071); Melted (1385); Device Emits Odor (1425)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	07/18/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Sysmex corporation (b)(4) confirmed that there is no risk of fire should this event recur.The wiring cord is manufactured using flame retardant material and is covered by a sheet metal enclosure.The wiring cords are not accessible to the user.The maximum voltage traveling through the wiring cord is 5v.The low voltage reduces the potential for shock.The cs-2000i / cs-2100i instructions for use (ifu), instruct the user in chapter 2 - safety information, section 2.2-general information: "should the instrument emit any unusual odors or smoke, turn the main switch off immediately and unplug the power cable.Contact your local sysmex technical representative.Failure to do so could result in fire, electrical shock or injury." the user followed the instructions and disconnected the analyzer from the power supply when the odor was first detected.
Event or Problem Description
The user reported a burnt odor emanating from the analyzer.The user immediately turned off and disconnected the analyzer from the power supply.There was no report of harm to the operator.A siemens field service engineer (fse) was dispatched to inspect the analyzer.The fse found melting and charring of wiring cord 3834.Wiring cord 3834 connects the hall element no.7 assembly to pcb no.1278.The fse installed a new sample table assembly, replaced the mixing motors and hall effect sensors, adjusted all temperatures and performed necessary sample arm and reagent arm adjustments.The fse adjusted the catcher to the dispensing wheel, performed all adjustments and checked the temperature.The fse then ran qc and deemed the analyzer operational.Part replacement and evidence based maintenance resolved the issue for the user.
Additional Manufacturer Narrative
Return of the suspect parts for investigation of root cause was requested.It was reported that the suspect parts were lost during transport and were no longer available.An investigation could not be performed.Root cause of the event could not be determined.Based on the data provided, sysmex corporation japan (s-corp) determined it is possible pinching of wiring cord 3834 contributed to the event.This is an isolated event, as no similar issue involving this part was reported.No further corrective action will be taken.

• Brand Name: SYSMEX CS-2100I AUTOMATED COAGULATION ANALYZER
• Common Device Name: CS-2100I
• Manufacturer (Section D): SYSMEX CORPORATION, I SQUARE; 262-11 mizuashi; noguchi-cho; kakogawa-city, 675-0 019; JA 675-0019
• MDR Report Key: 8853077
• Report Number: 1000515253-2019-00016
• Device Sequence Number: 372349
• Product Code: JPA
• UDI-Device Identifier: 04987562409471
• UDI-Public: 4987562409471
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K162688
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/11/2019

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: CS-2100I
• Device Catalogue Number: 06372511
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 07/24/2019
• Supplement Date Received by Manufacturer: 10/08/2019
• Initial Report FDA Received Date: 08/01/2019
• Supplement Report FDA Received Date: 10/11/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1