MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2020-03-13 for TRIMA ACCEL 80360 manufactured by Terumo Bct.
[186017535]
Investigation: according to aabb technical manual 16th edition, adverse events seen at the time of donation or those reported later average about 3. 5% of donations. Reactions that need medical care after the donor has left the donation site are seen in 1 in 3400 donors. (see sqs attachment pgs 195-196). Investigation is in process. A follow-up report will be provided.
Patient Sequence No: 1, Text Type: N, H10
[186017536]
The customer reported that during a donation procedure, a donor started to experience intense leg cramps, the experienced a brief loss of consciousness (about 10-20 seconds). The donor hit his head on the donor bed when he passed out. The staff administered first aid and gave the donor fluids by mouth. The donor was released from the donor room and went home. The next day the staff followed up with the donor. He still complained of a headache, so they suggested that the donor go to the er for follow up. The customer stated that the donor was diagnosed with a mild concussion. The donor was released from the er. The staff followed up after his release and stated he was doing ok and no follow up was necessary. Donor is currently in stable condition. The customer declined to provide patient (donor) age. The disposable set is not available for return because it was discarded by the customer.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1722028-2020-00111 |
| MDR Report Key | 9830623 |
| Report Source | HEALTH PROFESSIONAL |
| Date Received | 2020-03-13 |
| Date of Report | 2020-03-13 |
| Date of Event | 2020-01-15 |
| Date Mfgr Received | 2020-02-18 |
| Device Manufacturer Date | 2019-11-05 |
| Date Added to Maude | 2020-03-13 |
| 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 SAMPLER PLASMA AUTO RBC SET |
| Product Code | GKT |
| Date Received | 2020-03-13 |
| Model Number | 80360 |
| Catalog Number | 80360 |
| Lot Number | 1911052130 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| 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; 2. Required No Informationntervention | 2020-03-13 |