Catalog Number 80440 |
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 03/08/2018 |
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 bloodcell (rwbc) testing, therefore no patient information is reasonably known at the time of the event.Donor unit#: (b)(4) wbc count is not available at this time.The platelet collection 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 clarifying information and additional information.Investigation: there was no report of a white blood cell (wbc) failure, however, because the product was discarded, wbc count is not known.Per the run data file analysis, the trima displayed the message that the platelet product could be labeled as leukoreduced.The device history record (dhr) was reviewed for this lot.There were no issues noted in the dhr that would have contributed to the event experienced by the customer.Per the customer, the product appeared normal during collection and did not start to brighten until it had rested.Investigation by the customer found that these products did not have a suspect appearance during collection or while they were in donor services possession so there was nothing to alarm the tech to save the kit or flag the products to be tested.The tech was also evaluated loading, running and taking down three subsequent procedures to rule out kit installation error.The set was not saved for investigation since the unfavorable appearance of product was not until after collection and resting.A photo provided by the customer shows a picture with red blood cell (rbc) contamination settled out in the unit.A clear settling of rbcs can be seen in the picture.Root cause: the analysis of the run data file did not find a conclusive cause for the appearance of rbcs 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.
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Event Description
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Clarification of the event: the customer reported a collected platelet product failed qc due to its appearance.The customer stated there appeared to be red blood cells in the product.The customer discarded the product and did not perform qc testing.Therefore, white blood cell content in the product is not known.
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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.The analysis of the run data file did not find a conclusive cause for the appearance of rbcs 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.Investigation is in process.A follow-up report will be provided.
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Search Alerts/Recalls
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