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 Consequences Or Impact To Patient (2199)

Event Date 12/06/2019

Event Type  malfunction  

Manufacturer Narrative

The ts-10 instructions for use (ifu), chapter 2 - safety information, section 2.1 - general information, states, "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 unplugged after the odor was observed.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.The se replaced the fuse holder to resolve the issue.

Event Description

A user in (b)(6) reported a burning odor emanating from the tube sorter.A service engineer (se) was dispatched the next day and found the fuse holder was burnt.No smoke or fire was observed.No user or patient harm was incurred.

Manufacturer Narrative

Sysmex corporation (b)(4) (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, 399-0 702; JA 399-0702
• Manufacturer (Section G): SYSMEX RA CO. LTD.; 1850-3 hirookanomura; shiojiri, 399-0 702; JA 399-0702
• Manufacturer Contact: nancy gould ; 577 aptakisic rd; lincolnshire, IL 60069 ; 2245439678
• MDR Report Key: 9541146
• MDR Text Key: 178210047
• Report Number: 1000515253-2020-00001
• Device Sequence Number: 1
• Product Code: LXG
• UDI-Device Identifier: 04987562433155
• UDI-Public: (01)04987562433155
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 03/04/2020

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
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/07/2019
• Initial Date FDA Received: 01/02/2020
• Supplement Dates Manufacturer Received: 02/27/2020
• Supplement Dates FDA Received: 03/04/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/14/2017
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1