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U.S. Department of Health and Human Services

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

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BAXTER HEALTHCARE - LUND MONITORS PRISMAFLEX; DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM Back to Search Results
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.
 
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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 Key8456805
MDR Text Key140022370
Report Number9616026-2019-00015
Device Sequence Number1
Product Code KDI
Combination Product (y/n)N
PMA/PMN Number
K131516
Number of Events Reported1
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
Date FDA Received03/27/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue Number107493
Was Device Available for Evaluation? No
Was the Report Sent to FDA? Yes
Date Report Sent to FDA03/27/2019
Distributor Facility Aware Date03/04/2019
Event Location Hospital
Date Report to Manufacturer03/27/2019
Date Manufacturer Received05/02/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Death; Required Intervention;
Patient Age69 YR
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