Model Number 82616 |
Device Problems
High Readings (2459); 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 06/15/2021 |
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 double red blood cell 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.Donor unit #: (b)(6) the 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 analysis of the run data file did not find a conclusive cause for the higher-than-expected wbc content reported in rbc unit 2 for this collection.No unusual process variable was identified and the signals in the run data file indicate that the trima accel system operated as intended.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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Investigation: the run data file (rdf) was analyzed for this event.The analysis of the run data file did not find a conclusive cause for the higher-than-expected wbc content reported in rbc unit 2 for this collection.No unusual process variable was identified and the signals in the run data file indicate that the trima accel system operated as intended.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 analysis of the run data file did not find a conclusive cause for the higher-than-expected wbc content reported in rbc unit 2 for this collection.No unusual process variable was identified and the signals in the run data file indicate that the trima accel system operated as intended.
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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 double red blood cell 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.Donor unit #:(b)(6) the 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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