Catalog Number 80400 |
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 04/06/2017 |
Event Type
malfunction
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Manufacturer Narrative
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Lot number, expiry and manufacture data are not available at this time.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 wbc testing, therefore no patient information is reasonably known at the time of the event.White blood cell (wbc) count is not available at this time.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 additional information and corrected information.
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Event Description
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The customer did not respond to multiple attempts to obtain information for the investigation such as initial complainant's first name and lot information.
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Manufacturer Narrative
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This report is being filed to provide additional information.Investigation: 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.During customer follow-up, it was confirmed that the wbc count was below <5x10^6.The customer did not provide the lot number pertaining to this event, therefore a device history record (dhr) search could not be conducted for this specific incident.All lots must meet acceptance criteria before release.The run data file (rdf) was analyzed for this event.Root cause: review of the run data file showed that platelets did exit the lrs chamber as expected.It is possible, though not conclusive that wbcs may have exited the lrs chamber due to the multiple flow adjustments made.Based on the available information, it is also possible that this leukoreduction failure was donor related.
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Search Alerts/Recalls
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