Catalog Number 107640 |
Device Problems
Fluid/Blood Leak (1250); Material Split, Cut or Torn (4008)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 10/17/2021 |
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.Prismaflex st150 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.
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Event Description
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It was reported that during priming with a prismaflex st150, a fluid leak was observed from the drainage line shortly before the potential equalization from the hose line.Upon closer look, "an injury" to the hose was observed.There was no patient involvement reported.No additional information is available.
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Manufacturer Narrative
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H10: the actual device was provided for evaluation.A pressure test was performed and a leak was observed at the tube bld due to a hole.The reported condition was verified.The cause 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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