Catalog Number 800-0670A |
Device Problem
Separation Problem (4043)
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Patient Problem
No Information (3190)
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Event Date 09/05/2019 |
Event Type
malfunction
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Manufacturer Narrative
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(b)(4).Customer has indicated that the product is in process of being returned to zimmer biomet for investigation.Once the investigation has been completed, a follow-up mdr will be submitted.Report source: the event occurred in (b)(6).
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Event Description
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It was reported that during the procedure, the blood did not separate in the device.Attempts have been made, and no further information has been provided.
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Manufacturer Narrative
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This follow-up report is being submitted to relay additional information.Visual inspection of the returned tube noted some of the liquid, inside of the tubes has hardened with some still remaining in a liquid state.Device history record was reviewed and no discrepancies were found.Root cause was unable to be determined.If any further information is found which would change or alter any conclusions or information, a supplemental will be filed accordingly.Zimmer biomet will continue to monitor for trends.
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Event Description
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No further event information available at the time of this report.
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Search Alerts/Recalls
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