MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2020-03-17 for TRIMA ACCEL 80440 manufactured by Terumo Bct.
[186206890]
Investigation: the run data file (rdf) was analyzed for this event. The signals in the run data file indicate that the higher-than-expected wbc content in the platelet product was likely a result of an escape of wbc from the lrs chamber during the initial portion of the procedure when the lrs chamber is getting set-up and the platelet bed is getting established. The high influx of platelets may have inhibited the management of the lrs chamber contents. Based on the available information, it cannot be ruled out that the higher-than-expected wbc content in the platelet product could be donor-related. Investigation is in process. A follow-up report will be provided.
Patient Sequence No: 1, Text Type: N, H10
[186206891]
The customer would like the run data file investigated to determine a possible cause for the elevated white blood cell (wbc) content in the platelet product. There was not a transfusion recipient or patient involved at the time of the residual white blood cell (rwbc) testing, therefore no patient information is reasonably known at the time of the event. Donor unit #: w121520800327 the platelet collection set is not available for return because it was discarded by the customer.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1722028-2020-00114 |
| MDR Report Key | 9842076 |
| Report Source | HEALTH PROFESSIONAL |
| Date Received | 2020-03-17 |
| Date of Report | 2020-03-17 |
| Date of Event | 2020-02-13 |
| Date Mfgr Received | 2020-02-21 |
| Device Manufacturer Date | 2019-10-02 |
| Date Added to Maude | 2020-03-17 |
| 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 ENHANCED PLATELET, PLASMA, RBC SET |
| Product Code | GKT |
| Date Received | 2020-03-17 |
| Model Number | 80440 |
| Catalog Number | 80440 |
| Lot Number | 1910235151 |
| 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 | 2020-03-17 |