|
Catalog Number 80360 |
Device Problem
Product Quality Problem (1506)
|
Patient Problem
No Known Impact Or Consequence To Patient (2692)
|
Event Date 12/01/2015 |
Event Type
malfunction
|
Manufacturer Narrative
|
Investigation: the run data file (rdf) was analyzed for this event.The device history records (dhr) were reviewed for this lot.There were no events noted in the dhr that would have contributed to the elevated wbc count experienced by the customer.Root cause: a definitive root cause for the observed leukoreduction failure remains undetermined at this time.The signals in the run data file are consistent with some possible clumping/aggregation during platelet collection that could have affected the separation of cells in the lrs chamber.Based on the available information, it cannot be ruled out that the clumping/aggregation and resulting leukoreduction failure could be donor related.
|
|
Event Description
|
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 white blood cell (rwbc) testing, therefore no patient information is reasonably known at the time of the event.Donor unit #: (b)(6) the disposable kit is not available for return because it was discarded by the customer.
|
|
Search Alerts/Recalls
|
|
|