Catalog Number 107643 |
Device Problems
Fluid/Blood Leak (1250); Loose or Intermittent Connection (1371)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Type
malfunction
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Manufacturer Narrative
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The event occurred on an unspecified date in (b)(6) 2021.Prismaflex st60 set has been temporarily approved for use in the us under emergency use authorization (b)(4) to deliver crrt to treat patients in an acute care environment during the covid-19 pandemic.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 using a prismaflex st60 set, the effluent coupling was observed to be loose and the set "sucked air".The effluent bag was full of air and a leak of the effluent was observed outside the roller pump.There was no patient injury or medical intervention associated with this event.No additional information is available.
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Manufacturer Narrative
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Additional information added to h10.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; however, a video and a picture of the impacted set was provided.Their visual inspection observed air intake from the effluent pump segment.The reported condition was verified.The cause is a manufacturing issue due to the misassembly of both component by an operator.The operator is no longer with the company.Should additional relevant information become available, a supplemental report will be submitted.
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Search Alerts/Recalls
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