Model Number 80440 |
Device Problems
High Test Results (2457); 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 11/24/2019 |
Event Type
malfunction
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Manufacturer Narrative
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Lot number and expiry information are not available at this time 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 platelet 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 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 b.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.It was confirmed that the trima machine flagged the run for verification of wbc contamination.The lot number was not provided, therefore, a dhr search could not be conducted for this specific incident.All lots must meet acceptance criteria for release.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.Root cause: a conclusive root cause for the elevated level of wbcs in the platelet product could not be determined.Alerts that could contribute to wbc contamination of the platelet product, such as ¿centrifuge pressure high¿ or ¿rbc spillover¿, were not generated in this run data file.Possible causes include but are not limited to: a high donor wbc count, stopped centrifuge during the procedure, rbc detector calibration error, air block, and/or orientation of the tubing as loaded in the centrifuge hex holder compromised the structural integrity of the plasma tubing and caused a higher flow through the lrs chamber.
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Manufacturer Narrative
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This report is being filed to provide additional information in h.10.Corrective action: an internal capa has been opened to evaluate white blood cell (wbc) contamination in relation to a recent increase in the number of reported wbc contaminations.
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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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Search Alerts/Recalls
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