Catalog Number 80520 |
Device Problems
Device Operational Issue (2914); Insufficient Information (3190)
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Patient Problem
No Patient Involvement (2645)
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Event Date 09/06/2017 |
Event Type
malfunction
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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.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 red blood cell (rbc) product.There was not a transfusion recipient or patient involved at the time of the residual white bloodcell (rwbc) testing, therefore no patient information is reasonably known at the time of the event.Donor unit #: (b)(6).The rbc 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.Investigation: the run data file (rdf) was analyzed for this event.Root cause: a definitive root cause for the observed leukoreduction failure remains undetermined at this time.The analysis of the rdf did not find a conclusive cause for the higher-than-expected wbc content reported in the rbc product 2 for this collection.No unusual process variable was identified and the signals in the rdf indicate that the trima accelsystem operated as intended.Based on the available information, it is possible that the filter was unloaded from the filter bracket and loaded again during rbc collection or rbc additive solution addition, which could have a similar affect to ¿squeezing¿ the filter when using a gravity drain system.It is also possible that the reported results could be attributed to an issue with the filter.
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Search Alerts/Recalls
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