BAXTER HEALTHCARE CORPORATION PRISMAFLEX SETS (HF20); DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM
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Catalog Number 109841 |
Device Problems
Device Alarm System (1012); Protective Measures Problem (3015)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 04/10/2023 |
Event Type
malfunction
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Event Description
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It was reported that during continuous renal replacement therapy with a prismaflex control unit and a prismaflex hf20 set, multiple alarm conditions related to self-test failure were reportedly generated.The treatment was ended without the extracorporeal (ec) blood being returned to the patient two times.After the patient was switched to different model of prismaflex set, the treatment was performed without further issues using the same prismaflex control unit.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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Prismaflex hf20 set has been temporarily approved for use in the us under emergency use authorization eua (b)(4) to provide continuous renal replacement therapy (crrt) to treat low weight (8 kg to 20 kg) and low blood volume patients or patients who have acute renal failure, fluid overload, or both, and who cannot tolerate a larger extracorporeal circuit volume in an acute care environment during the coronavirus disease 2019 (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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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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