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 2020-03-20 for TRIMA ACCEL 80337 manufactured by Terumo Bct.
[186415590]
Investigation: the set was returned for evaluation. Terumo bct japan confirmed that air was in the set. No defects were found with the set upon evaluation. Investigation is in process. A follow up report will be provided.
Patient Sequence No: 1, Text Type: N, H10
[186415591]
The customer reported that during setup, an alarm pressure test failure occurred. The customer connected the needle to the donor and opened the clamp on the donor line and the diversion bag line to take a sample of blood. The operator then noticed air in the diversion bag and closed the clamps. Following the event, the donation room staff checked the health condition of donor 2 times (at that time and when the donor got home). The donor reported that they "didn't feel bad" and the customer judged there was no actual injury or impact to donor safety. Patient information is not available at this time. This product is not available within the us, but this report is being filed due to an alleged failure that could occur on a similarly marketed device platform cleared for use by the fda.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1722028-2020-00129 |
| MDR Report Key | 9860652 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL |
| Date Received | 2020-03-20 |
| Date of Report | 2020-03-20 |
| Date of Event | 2020-02-22 |
| Date Mfgr Received | 2020-02-26 |
| Device Manufacturer Date | 2019-08-01 |
| Date Added to Maude | 2020-03-20 |
| 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 | SCOT HILDEN |
| Manufacturer Street | 10810 W.COLLINS AVE |
| Manufacturer City | LAKEWOOD CO 80215 |
| Manufacturer Country | US |
| Manufacturer Postal | 80215 |
| Manufacturer Phone | 3032314970 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | TRIMA ACCEL |
| Generic Name | TRIMA ACCEL LRS PLATELET, PLASMA SET |
| Product Code | GKT |
| Date Received | 2020-03-20 |
| Returned To Mfg | 2020-03-03 |
| Catalog Number | 80337 |
| Lot Number | 1908194251 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| 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 | 2020-03-20 |