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Catalog Number 80400 |
Device Problems
Nonstandard Device (1420); Product Quality Problem (1506)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 12/17/2015 |
Event Type
malfunction
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Manufacturer Narrative
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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 lrs chamber during a portion of the procedure.Based on the available information, it cannot be ruled out that the higher-than-expected wbc content in the platelet product 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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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 blood cell (rwbc) testing, therefore no patient information is reasonably known at the time of the event.Donor unit #(b)(4) the disposable kit is not available for return, because it was discarded by the customer.
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Manufacturer Narrative
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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 include sampling, calculation, or other process error, or that the elevated wbc count could be donor-related.
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Search Alerts/Recalls
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