Model Number 82406 |
Device Problems
Contamination of Device Ingredient or Reagent (2901); 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 12/09/2021 |
Event Type
malfunction
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Manufacturer Narrative
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Investigation: 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 possibly a result of an escape of wbcs from the lrs chamber near the very end of the collection.Based on the available information, 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 following run data file investigated to determine a possible cause for the higher-than-expected wbc content in the platelet product.Donor unit #: (b)(6).The platelet collection set is not available for return because it was discarded by the customer.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.
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Event Description
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The customer would like the following run data file investigated to determine a possible cause for the higher-than-expected wbc content in the platelet product.Donor unit #: (b)(6) the platelet collection set is not available for return because it was discarded by the customer.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.
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Manufacturer Narrative
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This report is being filed to provided additional information in h.6 and h.10.Investigation: 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 possibly a result of an escape of wbcs from the lrs chamber near the very end of the collection.Based on the available information, it also cannot be ruled out that the higher-than-expected wbc content in the platelet product could be donor-related.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 following run data file investigated to determine a possible cause for the higher-than-expected wbc content in the platelet product.Donor unit #: (b)(4) the platelet collection set is not available for return because it was discarded by the customer.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.
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Manufacturer Narrative
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This report is being filed to provided additional information in h.6 and h.10.Investigation: 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 possibly a result of an escape of wbcs from the lrs chamber near the very end of the collection.Based on the available information, it also cannot be ruled out that the higher-than-expected wbc content in the platelet product could be donor-related.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: the signals in the run data file indicate that the higher-than-expected wbc content in the platelet product was possibly a result of an escape of wbcs from the lrs chamber near the very end of the collection.Based on the available information, 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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Search Alerts/Recalls
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