BAXTER HEALTHCARE CORPORATION PRISMAFLEX; DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM
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Catalog Number 107493 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Death (1802); Blood Loss (2597)
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Event Date 11/07/2019 |
Event Type
Death
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Manufacturer Narrative
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Should additional relevant information become available, a supplemental report will be submitted.
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Event Description
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It was reported that while disconnecting a patient off of therapy, an " error code 1 - blood pump failure" alarm occurred on the prismaflex control unit.The nurse was unable to return the blood and the patient.The amount of blood loss was not reported.It was reported the patient subsequently passed away.It was not reported if an autopsy was performed.No additional information is available.
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Manufacturer Narrative
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Additional information added to: a2, a3, a4, a5b, b5, b7, e4 and d11.B5: it was reported that following the blood pump alarm and while on the phone with a service representative for troubleshooting, the patient's blood pressure started to drop with mean arterial pressure in the 50's.Levo was bumped up to the maximum, 55 mcg/min.Epinephrine drip was started at 2 mcg/min.While still troubleshooting, the machine alerted error code 1, total system malfunction.The operator was instructed to restart the machine.After restarting, the machine was still malfunctioning and the operator was unable to return the blood to the patient.The reporter was instructed to disconnect the machine from the patient.The patient blood pressure continued to drop and the heart rate dropped at the 50's.Fourteen minutes after the original alarm, the intensive care unit team was at bedside.The patient was intubation with no cardiopulmonary resuscitation (cpr).Epinephrine drip was titrated to the maximum 10 mcg/min and then up to 20 mcg/min.1l lactated ringer's was given with pressure bag and the patient's blood pressure continued to stay low.It was reported the patient was intubated upon arrival to the hospital due to hypoxia that required 15l non rebreathing mask to maintain saturation and remained intubated on ventilator until the they expired fifty two minutes after the alarm.Should additional relevant information become available, a supplemental report will be submitted.
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Manufacturer Narrative
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Correction: g5.Additional information: f2, g3, h6 and h10.F2 - the customer reported this event to the fda through medwatch 9616026-2019-00064 and (b)(4).The device was not received for evaluation; therefore, a device analysis could not be completed.To date, baxter has not been provided with the treatment history files from the prismaflex control unit nor received any response to our requests for additional information related to the involved prismaflex control unit.The device reportedly operated as intended when the general system failure, code 1 alarmed while ending therapy.This alarm indicates that the blood pump mechanism has moved when ordered to stand still or has stood still when ordered to move.This alarm will prevent further treatment until resolved; however, blood can be returned manually by following the process described in the operator¿s manual.The prismaflex control unit enters a ¿safe state¿ by stopping all pumps and closing the return line clamp.A service history review revealed no indication that the parts replaced during servicing caused or contributed to the reported event.Should additional relevant information become available, a supplemental report will be submitted.
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Manufacturer Narrative
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Correction: removal of information in section f related to importer: the initial report inadvertently included the importer report number.This mdr should have been submitted only with the mfr.Number (and not as importer).
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Search Alerts/Recalls
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