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Catalog Number 5823102 |
Device Problems
Adverse Event Without Identified Device or Use Problem (2993); Insufficient Information (3190)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 03/15/2024 |
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.Run data file analysis did not show a conclusive root cause for the elevated wbc content in the platelet product reported for this collection.Alerts that are known to contribute to wbc contamination were not generated in this procedure.As the trima accel system cannot count the cells entering the platelet bag, the rbc detector signals must see a significant change in the reflectance values to notify the operator of an lrs chamber saturation and to count the wbcs in the platelet product.In this case, the signals did not indicate that wbcs were escaping the lrs chamber.Therefore, the run data file reported that the platelet product could be labeled as leukoreduced.Although the trima accel system has several methods for detection of possible wbc contamination, it is possible that some events may elude the detection capability of the trima accel system.It is also possible that this leukoreduction failure is 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.The platelet collection set is not available for return because it was discarded by the customer.This product is not available within the us, but this report is being filed due to an alleged failure that could occur on a similarly marketed device platform cleared for use by the fda.
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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.The platelet collection set is not available for return because it was discarded by the customer.This product is not available within the us, but this report is being filed due to an alleged failure that could occur on a similarly marketed device platform cleared for use by the fda.
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Manufacturer Narrative
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This report is being filed to provide additional information in d.4, h.6 and h.11.Investigation: the run data file (rdf) was analyzed for this event.Run data file analysis did not show a conclusive root cause for the elevated wbc content in the platelet product reported for this collection.Alerts that are known to contribute to wbc contamination were not generated in this procedure.As the trima accel system cannot count the cells entering the platelet bag, the rbc detector signals must see a significant change in the reflectance values to notify the operator of an lrs chamber saturation and to count the wbcs in the platelet product.In this case, the signals did not indicate that wbcs were escaping the lrs chamber.Therefore, the run data file reported that the platelet product could be labeled as leukoreduced.Although the trima accel system has several methods for detection of possible wbc contamination, it is possible that some events may elude the detection capability of the trima accel system.It is also possible that this leukoreduction failure is 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: run data file analysis did not show a conclusive root cause for the elevated wbc content in the platelet product reported for this collection.Alerts that are known to contribute to wbc contamination were not generated in this procedure.As the trima accel system cannot count the cells entering the platelet bag, the rbc detector signals must see a significant change in the reflectance values to notify the operator of an lrs chamber saturation and to count the wbcs in the platelet product.In this case, the signals did not indicate that wbcs were escaping the lrs chamber.Therefore, the run data file reported that the platelet product could be labeled as leukoreduced.Although the trima accel system has several methods for detection of possible wbc contamination, it is possible that some events may elude the detection capability of the trima accel system.It is also possible that this leukoreduction failure is donor related.
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Search Alerts/Recalls
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