Model Number 82406 |
Device Problems
Incorrect, Inadequate or Imprecise Result or Readings (1535); Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 10/18/2021 |
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.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 wbc testing, therefore no patient information is reasonably known at the time of the event.Donor unit #:(b)(4) 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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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.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.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.
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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.Donor unit #: (b)(6) the platelet collection is not available for return because it was discarded by the customer.
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Search Alerts/Recalls
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