MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 07 report with the FDA on 2011-12-19 for TRIMA ACCEL ENHANCED PLT, PLS, RBC SET 80449 manufactured by Caridianbct.
[17095667]
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 wbc testing, therefore no patient information is reasonably known at the time of the event. Donor unit #: (b)(4). The disposable set is unavailable for return because the customer discarded it. This report is being filed due to a device malfunction that has the potential for injury.
Patient Sequence No: 1, Text Type: D, B5
[17350041]
(b)(4). Investigation evaluation and corrective actions are in process. A follow-up report will be provided.
Patient Sequence No: 1, Text Type: N, H10
[170859239]
Caridian bct internal ref: (b)(4). This customer did not provide a lot number, so a device history record search could not be performed. All lots must meet acceptance criteria for release. After following up for more information about this run, the customer stated that the platelet product was actually collected on a spectra instead of trima, therefore no specific donor or procedure information was provided by the customer as there is not an rdf to analyze. Root cause: this disposable set was unavailable for specific root cause analysis. Due to lack of investigational evidence, a root cause could not be determined for the elevated residual wbc count. Investigation evaluation and corrective actions are in process. A f/u report will be provided.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1722028-2011-00475 |
| MDR Report Key | 2426701 |
| Report Source | 07 |
| Date Received | 2011-12-19 |
| Date of Report | 2011-11-22 |
| Date of Event | 2011-11-12 |
| Date Mfgr Received | 2011-11-22 |
| Date Added to Maude | 2012-04-18 |
| 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 | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | MATTHEW BICKFORD |
| Manufacturer Street | 10811 WEST COLLINS AVE. |
| Manufacturer City | LAKEWOOD CO 80215 |
| Manufacturer Country | US |
| Manufacturer Postal | 80215 |
| Manufacturer Phone | 3032052494 |
| 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 | 2011-12-19 |
| Catalog Number | 80449 |
| Lot Number | UNK |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| 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 | 2011-12-19 |