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 11/04/2020 |
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 u.S.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 a particulate matter was observed in the filter pod of a prismaflex st100 set during priming.No futhan was used.There was no patient involvement.No additional information is available.
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Manufacturer Narrative
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H10: the device was received for evaluation.Visual inspection did not identify any abnormalities that could have contributed to the reported condition.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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