MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign,health professional report with the FDA on 2020-01-02 for SYSMEX TS-10 BN168792 manufactured by Sysmex Ra Co. Ltd..
[178210047]
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.
Patient Sequence No: 1, Text Type: N, H10
[178210048]
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.
Patient Sequence No: 1, Text Type: D, B5
[183516099]
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.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1000515253-2020-00001 |
| MDR Report Key | 9541146 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL |
| Date Received | 2020-01-02 |
| Date of Report | 2020-03-04 |
| Date of Event | 2019-12-06 |
| Date Mfgr Received | 2020-02-27 |
| Device Manufacturer Date | 2017-04-14 |
| Date Added to Maude | 2020-01-02 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MRS. NANCY GOULD |
| Manufacturer Street | 577 APTAKISIC RD |
| Manufacturer City | LINCOLNSHIRE IL 60069 |
| Manufacturer Country | US |
| Manufacturer Postal | 60069 |
| Manufacturer Phone | 2245439678 |
| Manufacturer G1 | SYSMEX RA CO. LTD. |
| Manufacturer Street | 1850-3 HIROOKANOMURA |
| Manufacturer City | SHIOJIRI, 399-0702 |
| Manufacturer Country | JA |
| Manufacturer Postal Code | 399-0702 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | SYSMEX TS-10 |
| Generic Name | AUTOMATED TUBE SORTER |
| Product Code | LXG |
| Date Received | 2020-01-02 |
| Model Number | TS-10 |
| Catalog Number | BN168792 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | SYSMEX RA CO. LTD. |
| Manufacturer Address | 1850-3 HIROOKANOMURA SHIOJIRI, 399-0702 JA 399-0702 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2020-01-02 |