Catalog Number 80520 |
Device Problems
High Test Results (2457); Filtration Problem (2941)
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Patient Problems
No Patient Involvement (2645); No Information (3190)
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Event Date 05/27/2016 |
Event Type
malfunction
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Manufacturer Narrative
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Investigation: the run data file was analyzed for this procedure.The analysis of the run data file did not find a conclusive cause for the higher-than-expected wbc content reported in rbc product 2 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.It cannot be ruled out that this leukoreduction failure could be the result of an issue with the filter.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.The product is in quarantine and was not transfused.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.Donor unit # (b)(4), the disposable set is not available for return because it was discarded by the customer.
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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.Root cause: this disposable set was unavailable for specific root cause analysis.A definitive root cause for the observed leuko reduction failure remains undetermined at this time.No unusual process variable was identified and the signals in the run data file indicate that the trima accel system operated as intended.It cannot be ruled out that this leuko reduction failure could be the result of an issue with the filter.
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Search Alerts/Recalls
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