Model Number 82446 |
Device Problems
Device Ingredient or Reagent Problem (2910); 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 08/19/2020 |
Event Type
malfunction
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Manufacturer Narrative
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Investigations: the run data file (rdf) was analyzed for this event.The signals in the run data file indicate that the higher-than-expected wbc content in the platelet product was likely a result of an escape of wbcs from the lrs chamber that began near the start of the collection.Based on the signals, it cannot be ruled out that this disruption may have been due to an occlusion or air block in the plasma line in the centrifuge that disrupted the steady state of the system.Additionally, it also cannot be ruled out that the higher-than-expected wbc content in the platelet product could be donor-related.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.Donor unit #: (b)(6).The platelet 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 in h.6 and h.10.Investigation: a review of the device history record (dhr) for this unit showed no irregularities during manufacturing that were relevant to this issue.Root cause: the signals in the run data file indicate that the higher-than-expected wbc content in the platelet product was likely a result of an escape of wbcs from the lrs chamber that began near the start of the collection.Based on the signals, it cannot be ruled out that this disruption may have been due to an occlusion or air block in the plasma line in the centrifuge that disrupted the steady state of the system.Additionally, it also cannot be ruled out that the higher- than-expected wbc content in the platelet product could be donor-related.The customer had used horiba automated cell counter to enumerate the residual wbc count in the platelet product.It is possible that this cell counter is not capable of enumerating leukoreduced products with low wbc concentrations.
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Search Alerts/Recalls
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