Concomitant products: common device name: dialyzer, high permeability with or without sealed dialysate system.Mfr: nxstage medical, inc., 350 merrimack st., lawrence, ma, 01843, model number: nx-1000-5-a, serial number: (b)(6), brand name: nxstage system one, age of device: 2 years.Common device name: stopcock, i.V.Set, brand name: bd connecta plus stopcock, mfr: bd, san antonion, tx, model number: 394910, catalog number: 394910.
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Ufmw received on october 2, 2019.¿staff description: pt became disconnected from return port of continuous renal replacement therapy (crrt) and was pumping blood into the bed.No alarms went off on circuit.Disconnection was noted when blood pressure dropped.Crrt was stopped and lines were clamped.There appeared to be several hundred ml of blood in the bed.Blood pressure stabilized with increased pressors and stopping of crrt.Machine brought to clinical technology for evaluation.Sent log file to manufacturer for review.Verified parameters.Prime and alarms tests-passes.Mock treatment.Triggered venous high pressure to test audible alarm-audible alarm occurred.Machine appears to be working per specifications.According to the machine log, the venous return pressure was around 90mmhg just prior to disconnect.Pressure then dropped to around 36mmhg.Alarm limit was set at 20mmhg.Blood flow rate was 200ml/min.Blood loss estimate was around 1000ml.A key factor appears to be the use of the tego port and the 3-way stopcock on the venous return line.The stopcock was a newly introduced model and may be more prone to not locking properly on the threads.The line disconnected where the stopcock was attached to the tego port.Another factor is the small bore of the stopcock and tego connector provided enough back pressure to prevent the low pressure alarm from triggering.¿.
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H10: no d1005 product samples, videos, or photographs were returned for investigation.No dhr lot review was conducted because no lot number(s) was/were identified.A probable cause cannot be identified based on the information that has been provided.Additional information in d10 and g1.
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