Catalog Number 4720502083-3 |
Device Problems
Improper Flow or Infusion (2954); Infusion or Flow Problem (2964)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 08/20/2018 |
Event Type
malfunction
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Manufacturer Narrative
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(b)(4).Report source, foreign-event occured in (b)(6).The device will not be returned to the manufacturer.Therefore, it will not be analyze.The device manufacturing quality record could not been reviewed as the lot number was not communicated.With the available information, the exact root cause of the event could not 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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It has been reported that during the surgery it was not possible to fill the monomer liquid optipac 40 rbc from the bag.The system s have been thrown away, because of contamination.To complete the procedure refobacin bone cement has been used.
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Manufacturer Narrative
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(b)(4).This follow-up report is being submitted to relay additional information.The device will not be returned to the manufacturer.Therefore, it will not be analyzed.The device manufacturing quality record could not been reviewed as the lot number was not communicated.With the available information, the exact root cause of the event could not 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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It has been reported that during the surgery it was not possible to fill the monomer liquid optipac 40 refobacin bone cement from the bag.The system has been thrown away, because of contamination.To complete the procedure refobacin bone cement has been used.The storage condition of the product is : o room temperature 21°c.The operating room condition is : o room temperature 21°c.
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Search Alerts/Recalls
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