Model Number 82406 |
Device Problems
Device Ingredient or Reagent Problem (2910); Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
No Patient Involvement (2645); No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 09/15/2020 |
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 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.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 #: w047020317400005 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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The capa information provided in supplement 1 for this report is no longer relevant to this event and has been removed from the investigation.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: 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, the most likely root cause for the higher than expected wbc content is an increase in blood volume processed and possible donor specific blood characteristics that may challenge the trima leukoreduction system; including, but not limited to: a higher donor bmi, a donor pre-wbc count that is above the trima accel system expectation, larger than average donor platelet size, and/or smaller than average donor wbc or rbc size.
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Manufacturer Narrative
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Corrective action: an internal capa has been opened to evaluate white blood cell (wbc) contamination in relation to a recent increase in the number of reported wbc contaminations.Investigation is in process.A followup report will be provided.
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Search Alerts/Recalls
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