Catalog Number H938724 |
Device Problems
Fitting Problem (2183); Free or Unrestricted Flow (2945)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Type
malfunction
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Event Description
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It was reported that there was a connection issue with an unspecified quantity of em2400 valve sets.The events were further described as the ¿inlets are not occluding the lipid port when it is not in use and allowing some lipid to be pulled into fluids in which they don't belong.¿ it was further reported that when they tried to configure the tube set and bypass the lipid ports, it was just pulling air causing air in line issues.This issue occurred during compounding when running bags that were supposed to be clear normal saline (ns) and dextrose 5% in water (d5w) which appeared murky and cloudy from lipid contamination.As a result, cloudy solutions were discarded.Tpns (total parenteral nutrition) with lipids were in range so they were dispensed.There was no report of patient injury or medical intervention associated with this event.No additional information is available.
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Manufacturer Narrative
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Should additional relevant information become available, a supplemental report will be submitted.
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Manufacturer Narrative
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H10: a batch review was conducted and there were no deviations found related to this reported condition during the manufacture of this lot.The device was not received for evaluation; therefore, a device analysis could not be completed.Should additional relevant information become available, a supplemental report will be submitted.
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Manufacturer Narrative
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H10: the actual devices were not available; however, two (2) companion samples were received for evaluation.Unaided visual inspection did not identify any abnormalities that could have contributed to the reported condition.System level testing was performed on both samples using an in-lab compounder and no leaks were observed; accuracy testing met specifications.The reported condition was not verified on the companion samples.Should additional relevant information become available, a supplemental report will be submitted.
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Search Alerts/Recalls
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