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Catalog Number 82310 |
Device Problems
Incorrect, Inadequate or Imprecise Result or Readings (1535); Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problem
No Patient Involvement (2645)
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Event Date 04/15/2019 |
Event Type
malfunction
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Manufacturer Narrative
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Lot number and manufacture dates are not available at this time.Investigation: the run data file (rdf) was analyzed for this event.Run data file analysis did not show a conclusive root cause for the higher than expected wbc content measured in the platelet product reported for this collection.Based on the available information, it is possible though not conclusive, this failure may be donor related.This report was filed beyond the 30-day timeframe due to an internal processing error.An internal capa has been initiated to address the issue.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 unit processing, therefore no patient information is reasonably known at the time of the event.This product is not available within the us, but this report is being filed due to an alleged failure that could occur on a similarly marketed device platform cleared for use by the fda.The platelet collection 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 provide in investigation: the lot number was unavailable per the customer.The customer did notprovide the lot number pertaining to this event, therefore a device history record (dhr) searchcould not be conducted for this specific incident.All lots must meet acceptance criteria beforerelease.Root cause: a definitive root cause for the observed leukoreduction failure remainsundetermined at this time.Run data file analysis did not show a conclusive root cause for the higher than expected wbccontent measured in the platelet product reported for this collection.Based on the availableinformation, it is possible though not conclusive, this failure may be donor related.
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Search Alerts/Recalls
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