Model Number 80520 |
Device Problems
Incorrect, Inadequate or Imprecise Result or Readings (1535); Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problem
No Patient Involvement (2645)
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Event Date 06/30/2020 |
Event Type
malfunction
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Manufacturer Narrative
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Investigation: the run data file (rdf) was analyzed for this event.The signals in the run data file indicate that the higher-than-expected wbc content in the second unit of the double red cell collection could be due to the flow not going through the filter medium as expected.The centrifuge pressure was lower during the collection of the second unit, and the overall product volume of the second unit is higher than expected.This could be due to a faulty filter, filter misload, or if the filter had been removed from the bracket at any time during collection.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 red blood cell (rbc) product.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.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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This report is being filed to provide additional information in h.6 and h.10.Investigation: a review of the device history record (dhr) for this unit showed no irregularities during manufacturing that were relevant to this issue.Root cause: the signals in the run data file indicate that the higher-than-expected wbc content in the second unit of the double red cell collection could be due to the flow not going through the filter medium as expected.The centrifuge pressure was lower during the collection of the second unit, and the overall product volume of the second unit is higher than expected.This could be due to a faulty filter, filter misload, or if the filter had been removed from the bracket at any time during collection.
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Search Alerts/Recalls
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