Model Number 82446 |
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 02/14/2020 |
Event Type
malfunction
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Manufacturer Narrative
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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 #: w044220510406 the platelet collection set is not available for return because it was discarded by the customer.The wbc count is not available at this time.
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Manufacturer Narrative
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This report is being filed to provide additional information in b.6.Investigation is in process.A follow-up report will be provided.
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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.It is noted that there were 12 access pressure alerts throughout the procedure.A higher level of access pressure alerts that may have disrupted steady-state collection enough to have contributed to contamination.Root cause: the analysis of the run data file did not find a 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 higher- than-expected wbc content in the platelet product could be donor-related.This procedure did have indications of less than ideal venous access which may have impacted steady state collection and separation efficiency.
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Search Alerts/Recalls
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