MAUDE Adverse Event Report: SYSMEX CORPORATION, I SQUARE SYSMEX UF-5000 FULLY AUTOMATED URINE PARTICLE ANALYZER; URINE PARTICLE COUNTER

Model Number	UF-5000
Medical Device Problem Code	Smoking (1585)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	05/20/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Inspection of the instrument by a service engineer (se) determined the urine spill seeped into cv-11 instrument's power cord outlet causing a short circuit, generating sparks, smoke and a burning odor.The sysmex cv-11 instruction for use (ifu), chapter 2 - safety information, section 2.1 - general safety information, warns the user: "in the event the instrument emits an abnormal odor or any smoke, turn off the power switch immediately and disconnect the power plug from the wall socket.If the instrument is used continuously in that state, there is a potential that fire, electrical shock, or injury may result.Contact your sysmex technical representative for inspection.Take care not to spill urine or reagent or drop wire staples or paper clips into the instrument.Those may cause a short circuit or smoke emission.If such trouble should occur, turn off the power immediately and disconnect the power plug from the wall socket.Then contact your sysmex technical representative for inspection".The se confirmed with the user that when the rack stopped in the measurement line, an alarm was generated.The user pressed the "start" switch from the control panel of the cv-11 without first removing the racks that were situated on the conveyor line.The sysmex cv-11 ifu, chapter 8 - troubleshooting, section 8.1 - actions to resolve errors, informs the user: if an error occurs in the cv-11, st-10 and st-11, reset the rack in the right pool and clear the error.The user is instructed to remove the rack that is in the position indicated by the lit rack position indicator led, to check the number of the error indicator led and perform the actions corresponding to the number.If a foreign object is present, the user is instructed to remove the foreign object.Analysis of the cv-11 data logs by sysmex corporation (b)(4) (s-corp) determined a rack crash occurred during sample analysis.The instrument generated an error.When the user pushed the "start" button without removing the racks, a second error was generated.The user then removed the rack situated closest to the left rack pool and pushed the "start" button again.The second rack was moved to the left towards the left rack pool.The cv-11 utilizes a front and rear belt to transport a rack.The racks are sandwiched between belt protrusions.The belt protrusions aid in signaling the homing position of the belt to the sensor.The second rack tipped over and spilled sample onto the left pool rack when the transport mechanism pushed the rack onto the belt protrusion.Investigation by sysmex corporation (b)(4) (s-corp) is in process.
Event or Problem Description
In (b)(6), the user of a sysmex uf-5000 automated urine particle analyzer with a cv-11, urine sample transportation unit, serial number (sn) (b)(4), reported sparks, smoke and a burning odor coming from the cv-11 following a spill from a rack of urine samples.The user reported that the cv-11 had ceased operation unexpectedly, prompting a re-initialization.Upon re-initialization, the sample rack was pushed towards the left rack pool area that collects samples after analysis and tipped over, spilling the urine onto the conveyor.The user immediately cleaned the area, but within an hour of the spill, the user noted sparks, smoke and a burning odor coming from the cv-11.A fire extinguisher was deployed at the source of the smoke.There were no reports of harm to the users or patients due to the event.A new cv-11 was installed to resolve the issue.
Additional Manufacturer Narrative
Sysmex corporation (b)(4) (s-corp) performed the investigation.S-corp determined the sample spill entered the cv-11 conveyor from the back left, where the power cord is connected, causing the short circuit.S-corp is developing plates and sponges to absorb and divert liquid away from the electronic parts to prevent recurrence.

• Brand Name: SYSMEX UF-5000 FULLY AUTOMATED URINE PARTICLE ANALYZER
• Common Device Name: URINE PARTICLE COUNTER
• Manufacturer (Section D): SYSMEX CORPORATION, I SQUARE; 262-11 mizuashi; noguchi-cho; kakogawa-city, 675-0 019; JA 675-0019
• MDR Report Key: 8697169
• Report Number: 1000515253-2019-00014
• Device Sequence Number: 2663321
• Product Code: LKM
• UDI-Device Identifier: 04987562440139
• UDI-Public: 0104987562440139
• Combination Product (Y/N): N
• Initial Reporter Country: CI
• PMA/510(K) Number: K171883
• 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: Modification/Adjustment
• Type of Report: Initial,Followup
• Report Date (Section B): 08/22/2019

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: UF-5000
• Device Catalogue Number: BN344411
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 05/21/2019
• Supplement Date Received by Manufacturer: 07/25/2019
• Initial Report FDA Received Date: 06/13/2019
• Supplement Report FDA Received Date: 08/22/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1