Catalog Number 000000000000080440 |
Device Problem
Device Operates Differently Than Expected (2913)
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Patient Problem
No Patient Involvement (2645)
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Event Date 12/04/2014 |
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 single 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 analysis of the run data file did not find 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 signals in the run data file indicate that the trima accel system operated as intended.Based on the available information, it cannot be ruled out that the reported results could be donor related.It also cannot be ruled out that a sampling, calculation, or other process error could have contributed to the higher than expected wbc content in the platelet product.Investigation is in process.A follow-up report will be provided.
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Manufacturer Narrative
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This report is being filed to provide additional information.Investigation: the device history records were reviewed for this lot.There were no events noted in the dhr that would have contributed to the elevated wbc content 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.
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Search Alerts/Recalls
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