MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,05 report with the FDA on 2012-02-08 for TRIMA ACCEL ENHANCED PLT, PLS, RBC SET 80440 manufactured by Caridianbct.
[19652005]
(b)(4). Investigation: the run data file (rdf) was analyzed for this event. The rdf shows that the operator selected to abort the run at 29. 6 minutes and not at 47 minutes as was originally reported by the customer. Investigation evaluation and corrective actions are in-process. A follow-up report will be provided.
Patient Sequence No: 1, Text Type: N, H10
[19673641]
The customer reported that a donor had a vasovagal reaction during a platelet collection. The customer reported that the reaction occurred at 47 minutes into the collection. The procedure was ended. Patient identifier and age are not available at this time. It is unknown at this time if medical intervention was necessary for the vasovagal reaction. The disposable set is unavailable for return for evaluation. This report is being filed due to insufficient information provided at this time to determine if a malfunction with the potential for death or injury occurred.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1722028-2012-00073 |
| MDR Report Key | 2450931 |
| Report Source | 01,05 |
| Date Received | 2012-02-08 |
| Date of Report | 2012-01-12 |
| Date of Event | 2012-01-03 |
| Date Mfgr Received | 2012-01-12 |
| Date Added to Maude | 2012-07-31 |
| 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 | 0 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | KRISTEN COHEN |
| Manufacturer Street | 10811 WEST COLLINS AVE. |
| Manufacturer City | LAKEWOOD CO 80215 |
| Manufacturer Country | US |
| Manufacturer Postal | 80215 |
| Manufacturer Phone | 3032052870 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | TRIMA ACCEL ENHANCED PLT, PLS, RBC SET |
| Generic Name | AUTOMATED BLOOD CELL SEPARATOR |
| Product Code | LNI |
| Date Received | 2012-02-08 |
| Catalog Number | 80440 |
| Lot Number | UNK |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | CARIDIANBCT |
| Manufacturer Address | LAKEWOOD CO US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2012-02-08 |