MAUDE Adverse Event Report: SYSMEX RA CO. LTD. SYSMEX TS-10; AUTOMATED TUBE SORTER

Model Number TS-10

Device Problems Thermal Decomposition of Device (1071); Overheating of Device (1437)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 01/13/2020

Event Type  malfunction  

Manufacturer Narrative

The ts-10 instructions for use warn the user in chapter 2 - safety information, section 2.1 - general information: "in the unlikely event that the system emits an unusual odor or smoke, immediately turn off the main switch and unplug the power cable.Then contact your sysmex service representative.Continued use of the system in such conditions could result in fire, electrical shock or personal injury." the ts-10 was turned off by the user.Fuses are located in fuse holders at the back of the system behind a metal plate, not readily accessible to the user.Furthermore, the fuse holders are made of flame resistant material, reducing potential for combustion.Investigation by sysmex corporation (b)(4) (s-corp) is in process.

Event Description

During normal operation, a user in (b)(6) noted an odor emanating from the tube sorter.A service engineer was dispatched and found one fuse holder to be burned.Replacement of the affected fuse holder and fuse resolved the issue for the user.There was no report of harm to the operator or negative impact to patient management.

Manufacturer Narrative

Sysmex corporation japan (s-corp) completed the investigation.The investigation determined insufficient tightening of the fuse holder cap during the supplier assembly process caused the event.Insufficient contact between the fuse holder cap and the fuse led to heat generation causing the fuse holder to burn.S-corp was able to reproduce the issue.The fuse holder is made of flame resistant material.Flame resistant materials are designed to prevent combustion; however, still have the potential to burn.No other sysmex devices use these types of fuses.No users were injured or other areas of the device damaged due to the burnt fuse holder.S-corp issued a countermeasure to the supplier to increase the torque and confirm the cap is appropriately tightened.After confirmation, the supplier will mark the cap indicating the cap was tightened and confirmed.

• Brand Name: SYSMEX TS-10
• Type of Device: AUTOMATED TUBE SORTER
• Manufacturer (Section D): SYSMEX RA CO. LTD.; 1850-3 hirookanomura; shiojiri, nagano 399-0 702; JA 399-0702
• MDR Report Key: 9702399
• MDR Text Key: 179138176
• Report Number: 1000515253-2020-00005
• 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: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 03/05/2020

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: Health Professional
• Device Model Number: TS-10
• Device Catalogue Number: BN168792
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 01/13/2020
• Initial Date FDA Received: 02/12/2020
• Supplement Dates Manufacturer Received: 02/27/2020
• Supplement Dates FDA Received: 03/05/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1