Catalog Number 82460 |
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 05/04/2020 |
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 overflow into the platelet concentrate when the additive solution was added.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)(6).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 additional information in h.6 and h.10.Investigation: a review of the device history record (dhr) for this unit showed no irregularities during manufacturing that were relevant to this issue.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.
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Search Alerts/Recalls
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