Catalog Number 5803002 |
Device Problem
Insufficient Information (3190)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 02/27/2024 |
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 reported that after completing an apheresis platelet procedure on a trima device, the operator noticed that the collected platelet product looked red.The operator tested the product and found that the free hemoglobin content was high.There was not a transfusion recipient or patient involved at the time of the unit processing, 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: a photograph was submitted in lieu of the disposables set to aid in the investigation.The photograph shows used primary and secondary platelet bags, and associated tubing, from a trima accel disposable set.The photograph confirms the presence of a red tinge.No kinks or misassemblies are visible.A disposable complaint history search was performed for this lot and found zero reports for similar issues on this lot.Investigation is in process and a follow-up report will be provided.
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Event Description
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The customer reported that after completing an apheresis platelet procedure on a trima device, the operator noticed that the collected platelet product looked red.The operator tested the product and found that the free hemoglobin content was high.There was not a transfusion recipient or patient involved at the time of the unit processing, 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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