A follow up report will be submitted once the failure investigation has been completed.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.
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It was reported that on (b)(6) 2024 at 1900, chemotherapy infusion(cytarabine) was infused slower than intended duration.The medication was programmed as continuous infusion at the rate of 43ml/hour with a volume to be infused (vtbi) of 1000ml for 23.3 hours.Per customer, the infusion of the first bag was started on (b)(6) 2024 at 1330 and completed on (b)(6) 2024 at 1630 (approximately three hours over) and the second cytarabine bag which was started on (b)(6) 2024 at 1630 ran until next day at 1900 (approximately 2.5 hours over).There was patient involvement but no harm.
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It was reported that on 17-feb-2024 at 1900, chemotherapy infusion(cytarabine) was infused slower than intended duration.The medication was programmed as continuous infusion at the rate of 43ml/hour with a volume to be infused (vtbi) of 1000ml for 23.3 hours.Per customer, the infusion of the first bag was started on 15-feb-2024 at 1330 and completed on 16-feb-2024 at 1630 (approximately three hours over) and the second cytarabine bag which was started on 16-feb-2024 at 1630 ran until next day at 1900 (approximately 2.5 hours over).There was patient involvement but no harm.
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Omit : b21 - type of investigation not yet determined, c21 - results pending completion of investigation, d16 - conclusion not yet available.Additional information : device eval by manufacturer?, reason code for no evaluation, if other specify, imdrf annex a, b, c, d, g codes , remedial action required, remedial action # and manufacturer narrative.A device history record review is performed on each device reported in a mdr reportable event along with other methods of investigation as coded in section h6 of this mdr report.H3 other text : not applicable.Device evaluated by bd.
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