Catalog Number 82321 |
Device Problems
Device Operates Differently Than Expected (2913); 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 04/25/2018 |
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.(b)(6).The platelet collection is not available for return because it was discarded by the customer.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.
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Manufacturer Narrative
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This report is being filed to provide corrected information.
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Manufacturer Narrative
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This report is being filed to provide additional information and corrected information.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.Further evaluation of this event has determined that the device did not cause or contribute to a death or serious injury, nor is there a likely potential for death or serious injury associated with this event based on additional investigational information.The run data file (rdf) was analyzed for this event and it was determined that the trima machine operated as intended by flagging the product.The investigator also confirmed that the wbc count for each transfusible unit was 3.06x10^6, and therefore below the threshold of 5.0x10^6.Root cause: the analysis of the run data file did not show a conclusive root cause why the stop button was pressed.There were no events (alerts, adjustments) during the procedure that could explain why the stop button was pressed.A ¿verify wbcs in platelet product¿ message was created, as stopping of the centrifuge interrupts the steady state of the lrs chamber.
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Event Description
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The platelet collection set is not available for return because it was discarded by the customer.
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Search Alerts/Recalls
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