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Model Number 82406 |
Device Problems
High Test Results (2457); 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 01/10/2022 |
Event Type
malfunction
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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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Investigation: the run data file (rdf) was analyzed for this event.The signals indicate that the device was not able to accurately calibrate the rbc detector after the cassette was loaded, and was thus not able to monitor the procedure as expected.Additionally, the signals also show that the device was having difficulty establishing and maintaining steady state during the collection.It cannot be ruled out that the needle line access may have shifted and could potentially have impacted the draw flow rate.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 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.10.Investigation: the run data file (rdf) was analyzed for this event.The signals indicate that the device was not able to accurately calibrate the rbc detector after the cassette was loaded, and was thus not able to monitor the procedure as expected.Additionally, the signals also show that the device was having difficulty establishing and maintaining steady state during the collection.It cannot be ruled out that the needle line access may have shifted and could potentially have impacted the draw flow rate.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 indicate that the device was not able to accurately calibrate the rbc detector after the cassette was loaded, and was thus not able to monitor the procedure as expected.Additionally, the signals also show that the device was having difficulty establishing and maintaining steady state during the collection.It cannot be ruled out that the needle line access may have shifted and could potentially have impacted the draw flow rate.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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