MAUDE Adverse Event Report: SYSMEX CORPORATION SYSMEX TS-10; AUTOMATED TUBE SORTER

Model Number TS-10

Device Problem Detachment Of Device Component (1104)

Patient Problem No Patient Involvement (2645)

Event Date 12/11/2017

Event Type  malfunction  

Manufacturer Narrative

Any incident where the potential for shock, spark, or fire exists creates a potential for harm.The solenoid and control box are located in an area that is not accessible to the user, decreasing the risk of user harm.

Event Description

The user reported the inability to eject the drawer tray from the tube sorter.The field service engineer (fse) worked remotely with the user to eject the drawer tray.The fse was dispatched on (b)(6) 2017 and discovered the solenoid core, that controls the drawer tray release, fell onto a printed circuit board (pcb) in the control box.The fse stated the solenoid core dropping onto the pcb could create the potential for shock, spark, or fire.It is likely undue stress was placed on the drawer tray by attempting to open the drawer tray, which caused the solenoid core to fall onto the pcb.Once the solenoid fell, the user was able to eject the drawer tray.

Manufacturer Narrative

(b)(4) initiated a countermeasure to prevent the loosening of fixing screws.Vibrations due to normal use caused the fixing screw to become loose and the solenoid core to fall into the control box.The countermeasure consisted of increasing the tightening torque of the screws, changing the material of the spacer from resin to metal, and adding a screw and washer to the solenoid core.The service engineer (se) performed the countermeasure when dispatched.No further corrective action will be taken.

• Brand Name: SYSMEX TS-10
• Type of Device: AUTOMATED TUBE SORTER
• Manufacturer (Section D): SYSMEX CORPORATION; 314-2 kitano, noguchi-cho; kakogawa, 675-0 011; JA 675-0011
• MDR Report Key: 7180898
• MDR Text Key: 97084418
• Report Number: 1000515253-2018-00001
• Device Sequence Number: 1
• Product Code: LXG
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup
• Report Date: 06/29/2018

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
• Device Operator: Medical Technologist
• Device Model Number: TS-10
• Device Catalogue Number: BN168792
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 12/11/2017
• Initial Date FDA Received: 01/10/2018
• Supplement Dates Manufacturer Received: 01/25/2018
• Supplement Dates FDA Received: 06/29/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1