Catalog Number 107640 |
Device Problems
Crack (1135); Leak/Splash (1354)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 11/17/2021 |
Event Type
malfunction
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Event Description
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It was reported that a small crack (described as hair line) was observed in the plastic tubing of a prismaflex st150 connecting to the syringe.This resulted in the backflow and blood leak.There was no patient injury or medical intervention associated with this event.No additional information is available.
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Manufacturer Narrative
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Facility name: (b)(6).Prismaflex st150 set 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.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 not available; however, a photograph of the sample was provided for evaluation.The visual inspection showed a blood leakage from the anticoagulation line and that the customer used flolan product in the syringe connected to the anticoagulation line.The reported condition was verified.The cause is a therefore a user error.Flolan® (epoprostenol) is not an anticoagulant but a drug preventing platelet aggregation.The ifu of the prismaflex mentions the "anticoagulation line", so flolan® (epoprostenol) should not be injected from the anticoagulant line.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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