Catalog Number 80400 |
Device Problem
Device Operates Differently Than Expected (2913)
|
Patient Problem
No Known Impact Or Consequence To Patient (2692)
|
Event Date 05/25/2016 |
Event Type
malfunction
|
Manufacturer Narrative
|
Investigation: the run data file (rdf) was analyzed for this event.The signals in the run data file indicate that the higher than expected wbc content in the platelet product was likely a result of an escape of wbcs from the leukoreduction system (lrs) chamber at the end of the procedure.Based on the available information, it cannot be ruled out that the reported results could be donor related.Investigation is in progress.A follow-up report will be provided.
|
|
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 wbc testing, therefore no patient information is reasonably known at the time of the event.Donor unit #(b)(6).The disposable set is not available for return, because it was discarded by the customer.
|
|
Manufacturer Narrative
|
Investigation: 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: 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.
|
|
Search Alerts/Recalls
|