Catalog Number 107640 |
Device Problem
Fluid/Blood Leak (1250)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Type
malfunction
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Event Description
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It was reported that during the priming of two (2) of a prismaflex st150, a leak was observed at the connection between the tube and the filter.There was no patient involvement.No additional information is available.
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Manufacturer Narrative
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Initial reporter phone no.: (b)(6).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.Should additional relevant information become available, a supplemental report will be submitted.
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Manufacturer Narrative
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The actual device was received for evaluation.An air pressure leak test was performed and a leak was observed at the level of the dialysate port due to a crack on the housing of the dialysate port.The cause of the crack was due to a mechanical shock applied to the product during transportation/shipping.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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Manufacturer Narrative
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Corrected information added to b5: only one (1) unit from lot #21i1903 was involved in the reported event.Should additional relevant information become available, a supplemental report will be submitted.
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Search Alerts/Recalls
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