Catalog Number 109841 |
Device Problem
Inaccurate Information (4051)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 06/06/2022 |
Event Type
malfunction
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Event Description
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It was reported that an error in translation regarding pediatric patients weight occurred when translating instructions for use from the english language to estonian or baltic counties on a prismaflex set hf20 occurred regarding the pediatric patients weight.There was no patient involvement.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 eua201769 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 actual device was not available for investigation; however, a retained sample of instruction for use (ifu) was evaluated.The estonian ifu translated into english states: "prismaflex m60 should not be used in children weighing more than 11 kg.Prismaflex m100 and m150 kits should not be used in patients with body weight exceeding 30 kg.¿ the correct sentence in the english ifu states: "prismaflex m60 should be restricted to children with a body weight greater than 11 kg, and m100/150 sets should be restricted to patients with a body weight greater than 30kg.¿ the reported condition was verified.A nonconformance has been opened to address this issue.Should additional relevant information become available, a supplemental report will be submitted.
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Search Alerts/Recalls
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