Catalog Number 955467 |
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 01/30/2024 |
Event Type
malfunction
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Event Description
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It was reported that an external fluid leak was observed from the disconnected effluent fluid line of a prismaflex st150 set two hours after starting continuous renal replacement therapy.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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E1: facility name: (b)(6) hospital 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 device was not available; however, photographs of the sample were provided for evaluation.Visual inspection of the photos showed that the effluent pump segment was disconnected from the support plate.A batch review was conducted and there were no deviations found related to this reported condition during the manufacture of this lot.The reported condition was verified.The cause of the condition was determined to be related to the manufacturing process of solvent application between the parts.Nonconformance and corrective action preventive action records were opened to address this issue.Should additional relevant information become available, a supplemental report will be submitted.
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Search Alerts/Recalls
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