Catalog Number 115309 |
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 07/29/2022 |
Event Type
malfunction
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Event Description
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It was reported that during priming with a prismaflex t100, an external fluid leak was observed from the vein chamber "low side" due to a rip.There was no patient involvement.No additional information is available.
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Manufacturer Narrative
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Initial reporter name and address: phone no: (b)(6).Should additional relevant information become available, a supplemental report will be submitted.Prismaflex st100 set ckt has been temporarily approved for use in the us under emergency use authorization eua: (b)(4) to deliver crrt to treat patients in an acute care environment during the covid-19 pandemic.
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Manufacturer Narrative
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H10: the device was received for evaluation.Visual inspection and an air leak test was performed with no anomalies noted.The reported condition was not verified.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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