Catalog Number 80400 |
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 02/04/2019 |
Event Type
malfunction
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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.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 wbc from the lrs chamber during the latter 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.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 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 root cause: a definitive root cause could not be determined.The signals in the run data fileindicate that the higher-than-expected wbc content in the platelet product was possibly a resultof an escape of wbc from the lrs chamber during the latter portion of the procedure.Based onthe available information, it cannot be ruled out that the higher-than-expected wbc content inthe platelet product could be donor-related.
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Search Alerts/Recalls
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