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Catalog Number 4824062 |
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 03/04/2024 |
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 reported in the platelet product was possibly the result of a wbc saturation of the lrs chamber at multiple points in the procedure fell which fell just under the detection threshold for flagging the platelet product for wbc verification.The signals in the run data file indicate that the device had difficulty establishing and maintaining steady state operation during the procedure, so it cannot be ruled out that the needle line access may have shifted and could potentially have impacted the collection.Additionally, based on the available information, it cannot be ruled out that the higher-than-expected wbc content in the platelet product may have been 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.Donor unit #: (b)(6) 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.
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Manufacturer Narrative
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This report is being filed to provide additional information in h.6 and h.11.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 reported in the platelet product was possibly the result of a wbc saturation of the lrs chamber at multiple points in the procedure fell which fell just under the detection threshold for flagging the platelet product for wbc verification.The signals in the run data file indicate that the device had difficulty establishing and maintaining steady state operation during the procedure, so it cannot be ruled out that the needle line access may have shifted and could potentially have impacted the collection.Additionally, based on the available information, it cannot be ruled out that the higher-than-expected wbc content in the platelet product may have been 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 reported in the platelet product was possibly the result of a wbc saturation of the lrs chamber at multiple points in the procedure fell which fell just under the detection threshold for flagging the platelet product for wbc verification.The signals in the run data file indicate that the device had difficulty establishing and maintaining steady state operation during the procedure, so it cannot be ruled out that the needle line access may have shifted and could potentially have impacted the collection.Additionally, based on the available information, it cannot be ruled out that the higher-than-expected wbc content in the platelet product may have been 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.Donor unit #: (b)(6) 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.
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Search Alerts/Recalls
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