Catalog Number 000000000000080440 |
Device Problem
Programming Issue (3014)
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Patient Problem
No Information (3190)
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Event Date 07/07/2015 |
Event Type
malfunction
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Manufacturer Narrative
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Investigation: the disposable set was unavailable for return and 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.Signals in the run data file do not indicate a conclusive cause for the greater than expected rwbc content in the platelet product for this collection.
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Event Description
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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 bloodcell (rwbc) testing, therefore no patient information is reasonably known at the time of the event.(b)(4) disposable set is not available for return because it was discarded by the customer.
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Manufacturer Narrative
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This report is being filed to correct information.
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Search Alerts/Recalls
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