MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2017-12-29 for 3ME-SC203A TSCDII 110V 3MESC203A manufactured by Terumo Bct.
[96235241]
Investigation: the customer stated that they performed 10 seals on the tubing line, however, black 'burn' marks were observed on the 3rd seal and was unable to complete the 7th seal due to error alarms. The tscdii device was returned to terumo bct for repair and investigation. A service technician visually inspected the device and noticed that the wafer cartridge was in the jammed position. The service technician carefully pryed the cartridge out and was unable to duplicate the reported condition. Simulated use testing was performed using the tscdii device. While providing multiple samples of burned welds and wafers, it was confirmed that the same wafer was being used over and over again causing burning of weld and wafer. Upon visual inspection, it was observed that one sample wafer had extreme corrosion while setting in the cartridge. It would have been the first in the cartridge at the open end. This may have been a problem and caused the block of wafers to stick and not advance while holding down the wafer cartridge switch. The service technician made many welds before the 30 test welds needed to perform a weld integrity test. No errors occurred. The cartridge was changed and additional 4 welds. The tscdii was returned to the customer and the customer installed the tscdii device. Investigation is in process. A follow-up report will be provided.
Patient Sequence No: 1, Text Type: N, H10
[96235242]
The customer reported that while sealing the tubing line using the trima sealer (tscdii)device, they received multiple error alarms including 'defective wafer, press reset' alarm and observed black 'burn' marks on the tubing line. The trima device was returned for repair and evaluation. Upon evaluation of the device, the terumo bct service technician discovered that multiple welds were made from a single-use wafer. Patient information is not available at this time.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1722028-2017-00521 |
| MDR Report Key | 7154098 |
| Report Source | HEALTH PROFESSIONAL |
| Date Received | 2017-12-29 |
| Date of Report | 2017-12-29 |
| Date of Event | 2017-11-16 |
| Date Mfgr Received | 2018-03-15 |
| Device Manufacturer Date | 2017-03-20 |
| Date Added to Maude | 2017-12-29 |
| 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 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | STEVE KERN |
| Manufacturer Street | 10810 W. COLLINS AVE |
| Manufacturer City | LAKEWOOD CO 80215 |
| Manufacturer Country | US |
| Manufacturer Postal | 80215 |
| Manufacturer Phone | 3032392246 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | 3ME-SC203A TSCDII 110V |
| Generic Name | TSCDII 110V |
| Product Code | KSB |
| Date Received | 2017-12-29 |
| Model Number | 3MESC203A |
| ID Number | 05020583300033 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | TERUMO BCT |
| Manufacturer Address | LAKEWOOD CO 80215 US 80215 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2017-12-29 |