MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2012-04-26 for TRIMA ACCEL ENHANCED PLT, PLS, SET 80449 manufactured by Caridianbct.
[2749138]
The customer would like the run data file investigated to determine a possible cause for the elevated wbc content that was measured in the platelet product collection. There was not a transfusion recipient or pt info is reasonably known at the time of the event. Donor unit# (b)(6). The disposable kit will not be returned as it has been discarded. This report is being filed due to a device malfunction that has the potential for injury.
Patient Sequence No: 1, Text Type: D, B5
[9832382]
(b)(4). The run data file (rdf) was analyzed. The analysis did not find a conclusive cause of the elevated wbc content reported for this collection. Signals in the run data file indicate it is possible, though not conclusive, that the plasma line may have been partially occluded near the end of the procedure. If the plasma line does not contribute properly to the platelet pump, it could cause the flow through the lrs chamber to be higher than the system expects, possibly allowing some wbcs to escape. Orientation of the hex in the hex holder may contribute to the above. Investigation eval and corrective actions are in process. A follow up report will be provided.
Patient Sequence No: 1, Text Type: N, H10
[10163817]
(b)(4). This report is being filed to provide additional information. There were no events noted in the device history record (dhr) that would have contributed to the elevated wbc count experienced by the customer. Root cause: the rdf analysis did not find a conclusive cause of the elevated wbc content reported for this collection. Possible root causes were provided in the initial report for this event. Internal capas have been initiated to evaluate reports of elevated wbc counts.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1722028-2012-00251 |
| MDR Report Key | 2557826 |
| Report Source | 05 |
| Date Received | 2012-04-26 |
| Date of Report | 2012-03-30 |
| Date of Event | 2012-02-21 |
| Date Mfgr Received | 2012-09-12 |
| Device Manufacturer Date | 2011-12-01 |
| Date Added to Maude | 2012-09-14 |
| 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 |
| Manufacturer G1 | GAMBRO BCT, INC. |
| Manufacturer Street | 10811 WEST COLLINS AVE. |
| Manufacturer City | LAKEWOOD CO 80215 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 80215 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | TRIMA ACCEL ENHANCED PLT, PLS, SET |
| Generic Name | AUTOMATED BLOOD CELL SEPARATED |
| Product Code | LNI |
| Date Received | 2012-04-26 |
| Catalog Number | 80449 |
| Lot Number | 12T1109 |
| Device Expiration Date | 2013-12-01 |
| 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 80215 US 80215 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2012-04-26 |