Per 803.52(f)(11)(iii) the information provided represents all of the known information at this time.The complainant or reporter was unable or unwilling to provide any further patient, product, or procedural details to the manufacturer.H3 other text : device was not returned to manufacturing facility.
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It was reported that a 24-hour mtx infusion ran for 24 hours and 32 minutes.Per report, it was "sped up after 12 hours and was left speed up for the entire 2nd 11.75 hour bag." even with being speed up, mtx still came down 32 minutes late.This was reported to bd representatives during their site visit.There was patient involvement but unknown outcome.
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