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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: GAMBRO LUNDIA AB PRISMAFLEX; DIALYZER, HIGH PERMEABILITY DIALYSATE SYSTEM
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GAMBRO LUNDIA AB PRISMAFLEX; DIALYZER, HIGH PERMEABILITY DIALYSATE SYSTEM Back to Search Results
Model Number 107493
Device Problem Device Alarm System (1012)
Patient Problems Death (1802); Low Blood Pressure/ Hypotension (1914)
Event Date 11/07/2019
Event Type  Death  
Event Description
Crrt machine started alarming around 2200.Alarm stated a problem with blood pump and blood flow rate incorrect.Gambro was called to trouble shoot the machine.While on the phone with gambro, pt blood pressure started to drop with maps in the 50's.Levo was bumped up to max, 55 mcg/min.Epi gtt was started at 2 mcg/min while still on the phone with gambro.Crrt machine alerted error code 1, total system malfunction, and gambro instructed me to restart machine.After restarting the machine was still malfunctioning, unable to return the blood to the patient, and gambro instructed me to disconnect from patient and have the machine inspected for the blood pump issue.At this point, pt blood pressure was dropping again and heart rate dropped the 50's.Icu team at bedside at 22:14.Pt code status intubation with no cpr.Epi gtt titrated to max, 10 mcg/min and then instructed to go up to 20 mcg/min per micu fellow.1 l lr given with pressure bag.Pt blood pressure continued to stay low.Tod (time of death) pronounced at 22:52.
 
Event Description
Crrt machine started alarming around 2200.Alarm stated a problem with blood pump and blood flow rate incorrect.Gambro was called to trouble shoot the machine.While on the phone with gambro, pt blood pressure started to drop with maps in the 50's.Levo was bumped up to max, 55 mcg/min.Epi gtt was started at 2 mcg/min while still on the phone with gambro.Crrt machine alerted error code 1, total system malfunction, and gambro instructed me to restart machine.After restarting the machine was still malfunctioning, unable to return the blood to the patient, and gambro instructed me to disconnect from patient and have the machine inspected for the blood pump issue.At this point, pt blood pressure was dropping again and heart rate dropped the 50's.Icu team at bedside at 22:14.Pt code status intubation with no cpr.Epi gtt titrated to max, 10 mcg/min and then instructed to go up to 20 mcg/min per micu fellow.1 l lr given with pressure bag.Pt blood pressure continued to stay low.Tod (time of death) pronounced at 22:52.I (the rn) called the help number when i was having issues with the machine with an error message coming up.I was troubleshooting the machine with the technician on the phone.The machine gave me multiple error messages during this time period where i was on the phone with the technician.During the troubleshooting, the machine was going longer and longer without actually circulating the blood and by the end of the phone call, some of the blood had visibly clotted in the filter and tubing lines.I believe the final error message said something like "total system malfunction" and there was no longer the option to return blood on the screen and the blood looked clotted in the filter.The technician on the phone instructed to not return the blood as well.Ccrt removed at this time in the plan of care because gambro instructed nurse to disconnect patient at which time the blood pressure was dropping and heart rate dropped in the 50's.Nurses note: icu team at bedside.Epi gtt titrated to max, 10 mcg/min and then instructed to go up to 20 mcg/min per micu fellow.1 l lr given with pressure bag.Pt blood pressure continued to stay low, family was notified by micu md.Pt code status intubation with no cpr.Pt tod pronounced at 22:52.The cause of death listed in the medical record is septic shock.Device software was updated on [date redacted], version 7.2.1.No autopsy to be performed.
 
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Brand Name
PRISMAFLEX
Type of Device
DIALYZER, HIGH PERMEABILITY DIALYSATE SYSTEM
Manufacturer (Section D)
GAMBRO LUNDIA AB
one baxter parkway
deerfield IL 60015
MDR Report Key9415668
MDR Text Key169233347
Report Number9415668
Device Sequence Number1
Product Code KDI
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source User Facility
Type of Report Initial,Followup
Report Date 11/19/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/05/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model Number107493
Device Catalogue Number107493
Was Device Available for Evaluation? Yes
Was the Report Sent to FDA? Yes
Date Report Sent to FDA11/19/2019
Event Location Hospital
Date Report to Manufacturer12/05/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Death;
Patient Age31390 DA
Patient Weight89
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