Catalog Number ASKU |
Device Problems
Fluid/Blood Leak (1250); Material Rupture (1546)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 05/05/2023 |
Event Type
malfunction
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Manufacturer Narrative
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Initial reporter address - (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 treatment with continuous renal replacement therapy (crrt) using an unspecified type of prismaflex set and a prismax machine, the bloodlines of the prismaflex set ruptured resulting in a blood leak.There was no report of patient injury or medical intervention associated with this event.No additional information is available.
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Manufacturer Narrative
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H10: the device was not returned and the lot number is unknown; 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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