Model Number 80410 |
Device Problems
Adverse Event Without Identified Device or Use Problem (2993); Therapeutic or Diagnostic Output Failure (3023)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 01/28/2021 |
Event Type
malfunction
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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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Event Description
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The customer would like the run data file investigated to determine a possible cause for the platelet product being red.There was not a transfusion recipient or patient involved at the time of the residual white blood cell (rwbc) 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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This report is being filed to provide additional information in h.6 and h.10.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.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 e.1, e.3, h.6 and h.10.Investigation: a photograph was provided in lieu of the disposable to aid in the investigation.The photo confirms the contents of the platelet bag have a red tint.The contents of the collection bag tubing are an expected color.This is indicative of a spillover at some point during the procedure.The distributor confirmed the dlog was not able for analysis.The customer was unable to answer whether or not the machine flagged or indicated to label the platelet product as leukoreduced.The customer did not allege white cell contamination and confirmed that the plasma was clear ruling out any concern for hemolysis.Root cause: a definitive root cause for the visual spillover could not be determined.An rbc spillover is generally related to an interface issue in the channel of the tubing set.Possible causes include but are not limited to: inaccurate hematocrit/hemoglobin entry.A procedure error.Donor blood variables.A disposables kit issue.A machine issue.A centrifuge stop.A tubing set loading error.
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Search Alerts/Recalls
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