Catalog Number 115309 |
Device Problem
Device Contamination with Chemical or Other Material (2944)
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Patient Problem
No Patient Involvement (2645)
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Event Date 11/07/2020 |
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.The device has been received and the evaluation is in progress.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 priming with a prismaflex st100 there was a particle in the set (filter pod).The anticoagulant futhan was not used.There was no patient involvement.No additional information is available.
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Manufacturer Narrative
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Additional information: h3, h6 and h10.H10: the device was received for evaluation.Visual inspection did not identify the reported condition.The reported condition was not verified.The cause of the condition 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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