MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-06-15 for 3ME-SC203A TSCDII 110V 3MESC203A manufactured by Terumo Bct.
[112285079]
Investigation: per customer the welds looked "charred"and they found that the wafer in the box was bent, preventing the wafer from advancing. A used wafer and partially consumed cartridge was received by terumo bct for evaluation. To avoid risk of exposure, the cartridge and wafer remained within the biohazard bag during visual inspection. Upon visual inspection, it was found that the used wafer had a viscous and burnt material on each side. One side showed the material in a rectangular shape and appeared mostly amber with some darker brown areas near the midsection of the wafer. The other side showed two distinct circular areas where the material had settled onto the wafer which were also amber in color and slightly darker in some areas, likely due to excessive heating. A horizontal line was observed within the wafer material on this side that was more deeply cut into the copper material than on the other side. There was no observable bowing or denting of the wafer that had been used. The cartridge was closely inspected and found to have a bent wafer that was impeding it from advancing. Investigation is in process. A follow-up report will be provided.
Patient Sequence No: 1, Text Type: N, H10
[112285080]
The customer reported that while welding tubing to create a split unit of an autologous stemcell collection, the welder did not eject the wafer and multiple welds were created using the same wafer. The customer stated that one of the units had tested positive for (b)(6). There were 2 donors with 3 donations involved and a total of six products aliquoted and frozen. Per the customer, none of the units were transfused. Unit id #1: (b)(4) - split unit (first product) the customer declined to provide the donor age, gender, weight and outcome.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1722028-2018-00172 |
| MDR Report Key | 7605517 |
| Date Received | 2018-06-15 |
| Date of Report | 2018-06-15 |
| Date of Event | 2018-05-24 |
| Date Mfgr Received | 2018-09-26 |
| Device Manufacturer Date | 2016-10-11 |
| Date Added to Maude | 2018-06-15 |
| 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 | 2018-06-15 |
| Returned To Mfg | 2018-06-01 |
| Model Number | 3MESC203A |
| ID Number | 05020583300033 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| 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 | 2018-06-15 |