Catalog Number 115309 |
Device Problem
Fluid/Blood Leak (1250)
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Patient Problem
No Patient Involvement (2645)
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Event Date 01/20/2021 |
Event Type
malfunction
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Manufacturer Narrative
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Prismaflex st100 set ckt 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.Initial reporter pone number: (b)(6).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 an external fluid leak was observed on a prismaflex st100 set during priming.There was no patient involvement.No additional information is available.
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Manufacturer Narrative
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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 received for evaluation.A visual inspection, a leak test and a simulated test were performed and the reported condition was not verified.Should additional relevant information become available, a supplemental report will be submitted.
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Manufacturer Narrative
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Correction: b4/f8: date of this report in mdr follow up #1 is being corrected from blank to 03/05/2021.
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Search Alerts/Recalls
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