Catalog Number 115312 |
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 07/13/2022 |
Event Type
malfunction
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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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Event Description
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It was reported that during treatment, one unit of prismaflex hf1400, the stopcock "came out" and a 5l external fluid leak was observed.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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Upon further review, it was determined that this device (product code 115312) is not same as or similar to a device that is manufactured or distributed in the us.Should additional relevant information become available, a supplemental report will be submitted.
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Search Alerts/Recalls
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