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Catalog Number H938724 |
Device Problems
Fluid/Blood Leak (1250); Detachment of Device or Device Component (2907)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 12/08/2023 |
Event Type
malfunction
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Event Description
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It was reported that an em2400 valve set had a connection issue.This was noticed during preparation, when pumping a patient order.The connector to the eva bag became disconnected from the tube and caused a spill.There was no patient involvement.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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H4: device manufacture date: the lot was manufactured from may 12, 2023 to may 14, 2023.H10: the actual sample was returned for evaluation.A visual inspection with the unaided eye observed the valve set connector was detached from the valve set silicone tubing.The reported condition was verified.The cause of the condition could not be determined.A batch review was conducted and there were no deviations found related to this reported condition during the manufacture of this lot.Should additional relevant information become available, a supplemental report will be submitted.
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Search Alerts/Recalls
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