Catalog Number 107140 |
Device Problem
Material Deformation (2976)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 11/21/2018 |
Event Type
malfunction
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Manufacturer Narrative
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(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 during patient treatment with a prismaflex hf1000 set, a kink in the access blood line and clots were observed.The treatment was terminated without blood restitution.The same event occurred twice during the same day, on the same patient.The patient lost a total of 330mls blood and had a delay in treatment.There was no medical intervention reported with this event.The patient outcome was not reported.No additional information is available.
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Manufacturer Narrative
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Additional information: 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 not received for evaluation; therefore, a device analysis could not be completed.Should additional relevant information become available, a supplemental report will be submitted.
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Search Alerts/Recalls
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