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

Model Number TS-10

Device Problem Overheating of Device (1437)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/03/2018

Event Type  malfunction  

Manufacturer Narrative

When the odor was detected, the instrument was turned off and inspected.The inspection found one fuse holder in the back of the instrument to be melted.No other damage to any parts of the instrument was noted.Replacement of the affected fuse holder resolved the issue for the user.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." 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.Previous investigation by sysmex corporation (b)(4) (s-corp) 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.

Event Description

While readying the instrument for daily operation at a company training facility in germany, a melted plastic odor was detected from the instrument.There was no report of harm to the operator.

• Brand Name: 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
• Manufacturer (Section G): SYSMEX RA CO. LTD.; 1850-3 hirookanomura; shiojiri, nagano 399-0 702; JA 399-0702
• Manufacturer Contact: nancy gould ; 577 aptakisic rd; lincolnshire, il ; 5439678
• MDR Report Key: 9794759
• MDR Text Key: 202956215
• Report Number: 1000515253-2020-00009
• Device Sequence Number: 1
• Product Code: LXG
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• 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: Other
• Device Model Number: TS-10
• Device Catalogue Number: BN168792
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 08/03/2018
• Initial Date FDA Received: 03/05/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/01/2014
• 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