Catalog Number 2N3350 |
Device Problems
Crack (1135); Fluid/Blood Leak (1250)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 12/26/2020 |
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 a non-dehp micro-volume extension set leaked.The event was further reported as a " filter part is cracking".The event occurred during intermittent infusion.The nurse observed an unspecified pump alarming for an occlusion; however, the solution was observed on the floor and the nurse noted the filter was cracked.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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The device was received for evaluation.Visual inspection did not identify any abnormalities, that could have contributed to the reported condition.The sample underwent pressure and clear passage testing, and no blockage was noted.However, during pressure testing, at 45 psi a leak was observed in the air vent of the filter.The reported condition was verified.The cause of the condition could not be determined.This issue is being further investigated.Should additional relevant information become available, a supplemental report will be submitted.
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Manufacturer Narrative
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Additional information for h10: based on further investigation, the most probable cause was determined to be related to the end user/methods exceeding the product pressure specifications of 45psi.Should additional relevant information become available, a supplemental report will be submitted.
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Search Alerts/Recalls
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