Model Number 82520 |
Device Problems
Incorrect, Inadequate or Imprecise Result or Readings (1535); No Apparent Adverse Event (3189)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 02/17/2023 |
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.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.The wbc count is not available at this time.
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Manufacturer Narrative
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Investigation is in process, a follow-up report will be provided.
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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: further evaluation of this event has determined that the device did not cause or contribute to a death or serious injury, nor is there a likely potential for death or serious injury associated with this event based on additional investigational information.During customer follow-up, it was confirmed that the wbc count was below 5x10^6.No further reporting will be provided as this does not represent a reportable event.
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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.
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Search Alerts/Recalls
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