MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2012-06-15 for TRIMA ACCEL ENHANCED PLT, PLS, RBC SET 80449 manufactured by Terumo Bct.
[19996817]
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 pt involved at the time of the residual wbc testing, therefore no pt info 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
[20275392]
(b)(4). Investigation: the run data file (rdf) was analyzed for this event. The analysis fo the rdf did not find a conclusive cause for the higher than expected wbc content in the platelet product reported for this collection. No unusual process variable was identified and the trima accel system operated as intended. Based on the available info, it is possible that the higher than expected wbc content in the platelet product could be donor related. It also cannot be ruled out that a sampling or other process error may have contributed to the higher than expected wbc content in the platelet product. Investigation eval and corrective actions are in-process. A f/u report will be provided.
Patient Sequence No: 1, Text Type: N, H10
[21149278]
(b)(4). This report is being filed to provide additional information. The device history record was reviewed. Nothing was found that was related to this event. Root cause: this disposable set was unavailable for specific root cause analysis. A definitive root cause for the observed leukoreduction failure remains undetermined at this time. Possible root causes were provided in the initial report for this event. An internal capa has been initiated to evaluate reports of elevated wbc counts.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1722028-2012-00364 |
| MDR Report Key | 2631040 |
| Report Source | 05 |
| Date Received | 2012-06-15 |
| Date of Report | 2012-05-22 |
| Date of Event | 2012-05-17 |
| Date Mfgr Received | 2012-09-06 |
| Device Manufacturer Date | 2012-02-01 |
| Date Added to Maude | 2012-10-11 |
| 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 | KRISTEN COHEN |
| Manufacturer Street | 10811 W. 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 | 2012-06-15 |
| Catalog Number | 80449 |
| Lot Number | 02U1118 |
| Device Expiration Date | 2014-02-01 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | TERUMO BCT |
| Manufacturer Address | LAKEWOOD CO US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2012-06-15 |