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Catalog Number 000000000000080360 |
Device Problem
High Test Results (2457)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 11/11/2014 |
Event Type
malfunction
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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 wbc testing, therefore, no patient information 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.
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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 event.There were no events noted in the dhr that would have contributed to the elevated wbc count experienced by the customer.Root cause: signals in the run data file do not indicate a conclusive cause for the greater than expected rwbc content in the platelet product reported for this collection.No unusual process variable was identified in the run data file and the trima accel system operated as intended.Based on the available information it is possible that this leukoreduction failure could be donor-related.It also cannot be ruled out that a sampling, calculation, or other process error may have contributed to the higher than expected rwbc content in the platelet product.
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Search Alerts/Recalls
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