TRIMA ACCEL Adverse Event — Malfunction (MDR 1722028-2020-00188)
TRIMA ACCEL Adverse Event — Malfunction (MDR 1722028-2020-00188) is one of 9,000 device adverse events in the DeviceEvents dataset. Key details — Device: TRIMA ACCEL; Generic name: TRIMA ACCEL RBC PLT PLASMA SET; Manufacturer: TERUMO BCT.
| Device | TRIMA ACCEL |
|---|---|
| Generic name | TRIMA ACCEL RBC PLT PLASMA SET |
| Manufacturer | TERUMO BCT |
| Report number | 1722028-2020-00188 |
| Event type | Malfunction |
| Product problem | Y |
| Date received | 2020-04-27 |
| Report source | HEALTH PROFESSIONAL |
| Narrative | 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 PROCEDURE. BASED ON THE AVAILABLE INFORMATION, IT CANNOT BE RULED OUT THAT THE HIGHER-THAN-EXPECTED WBC CONTENT IN THE PLATELET PRODUCT COULD BE DONOR-R |
| Source | openFDA MAUDE (device adverse events) |
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