MAUDE Adverse Event Report: BAXTER HEALTHCARE - LUND MONITORS PRISMAFLEX; DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM

Catalog Number 107493

Device Problem Filling Problem (1233)

Patient Problems Cardiopulmonary Arrest (1765); Death (1802); Low Blood Pressure/ Hypotension (1914)

Event Date 02/25/2019

Event Type  Death  

Manufacturer Narrative

Should additional relevant information become available, a supplemental report will be submitted.

Event Description

It was reported that during continuous renal replacement therapy (crrt) using a prismaflex control unit, the patient experienced hypotension, coded multiple times and subsequently passed away.It was reported the patient underwent a quadruple bypass and was connected to the control unit for crrt.The patient fluid removal rate was set to 0.0 ml, however, the machine removed 115 ml in one hour, which resulted in the patient experiencing hypotension.It was reported crrt was ongoing for 4 hours then pulled an additional 94 ml.The patient received ¿suppressive support¿.During the procedure, the patient coded five times and was transferred to the cardiac intensive care unit.The following day the patient coded two times and subsequently passed away.The cause of death was not reported.It was not reported if an autopsy was performed.No additional information is available.

Manufacturer Narrative

Upon follow up it was reported the patient had triple valve surgery and was never stable without pressors or mechanical ventilation post operatively.The patient had been in surgery for 14 hours before coming to the unit and coded several times before starting crrt.It was reported an autopsy was not performed.The cause of death was due to cardiac failure, reported as ¿the main contributing factor to their death¿.It was reported "the alarms were reset several times the hour before the code" and ¿the machine is not in question in this patient¿s death¿.H10: the device was evaluated on site.A complete functional check and a simulated treatment were performed without any issues.The event history log review showed that the loss/gain limit was set by the operator to 400 ml.This was never reached during the treatment.The allowed value (adult range) is 100 to 400 ml.The maximum recorded error over the moving 3-hour window was 144 ml of fluid.The history logs confirmed that the control unit issued several caution: flow problem alarms related to the effluent and dialysate flows.These were cleared by the operator.A service history review revealed no indication that the parts replaced during servicing caused or contributed to the reported event.No device failure or malfunction was identified that could have caused of contributed to the reported event; therefore, the prismaflex device is no longer considered suspect product in this event.Should additional relevant information become available, a supplemental report will be submitted.

• Brand Name: PRISMAFLEX
• Type of Device: DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM
• Manufacturer (Section D): BAXTER HEALTHCARE - LUND MONITORS; lund skane lan
• MDR Report Key: 8456805
• MDR Text Key: 140022370
• Report Number: 9616026-2019-00015
• Device Sequence Number: 1
• Product Code: KDI
• Combination Product (y/n): N
• PMA/PMN Number: K131516
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 03/27/2019,05/17/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 107493
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 03/27/2019
• Distributor Facility Aware Date: 03/04/2019
• Event Location: Hospital
• Date Report to Manufacturer: 03/27/2019
• Initial Date Manufacturer Received: 03/04/2019
• Initial Date FDA Received: 03/27/2019
• Supplement Dates Manufacturer Received: 05/02/2019
• Supplement Dates FDA Received: 05/17/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Death; Required Intervention
• Patient Age: 69 YR