BAXTER HEALTHCARE CORPORATION PRISMAFLEX SETS (ST); DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM
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Catalog Number 107640 |
Device Problem
Air/Gas in Device (4062)
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Patient Problem
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)
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Event Date 10/23/2023 |
Event Type
Injury
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Event Description
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It was reported that a patient received continuous renal replacement therapy (crrt) using five prismaflex sets.It was further reported over the course of eight hours, five filters were required due to foam occurring on the access side.The reporter was unable to determine the source of air, and the issue reoccurred despite replacing the crrt machine and prismaflex set.It was specified that at least four treatments ended without blood restitution, and the reporter ¿believes¿ that the patient received a blood transfusion.No additional information is available.
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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.Visual inspection did not identify any abnormalities that could have contributed to the reported condition.Should additional relevant information become available, a supplemental report will be submitted.
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Search Alerts/Recalls
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