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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BAXTER HEALTHCARE CORPORATION PRISMAX DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM

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BAXTER HEALTHCARE CORPORATION PRISMAX DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM Back to Search Results
Catalog Number 955626
Device Problem Improper or Incorrect Procedure or Method (2017)
Patient Problems Low Blood Pressure/ Hypotension (1914); Blood Loss (2597)
Event Date 12/04/2020
Event Type  Injury  
Manufacturer Narrative
Should additional relevant information become available, a supplemental report will be submitted.
 
Event Description
It was reported that during veno-venous hemofiltration therapy using a prismax control unit and a prismaflex m150 set, a patient became hypotensive and was treated with norepinephrine and vasopressin. It was reported that the patient was in the intensive care unit and on a ventilator support at 100% and experiencing atrial fibrillation with rapid ventricular rate. Within a few minutes of connecting the patient, the blood flow rate (bfr) too low for thermax alarm and an unable to detect return alarm occurred. The bfr was increased from 100 ml/min to 150 ml/min resolving both alarms. At an unspecified time during treatment, the prismax machine generated alarms related to ¿access extremely negative¿ and ¿tmp increasing¿ and troubleshooting attempts failed to solve the conditions. The operator attempted to return the extracorporeal blood to the patient, but the blood return function on the prismax was reportedly not available. The treatment was terminated without returning the extracorporeal blood to the patient. The patient was reportedly hemodynamically unstable (no blood pressures provided) and the vasopressor medication was increased and phenylephrine was added. The patient outcome was not reported. No additional information is available.
 
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Brand NamePRISMAX
Type of DeviceDIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM
Manufacturer (Section D)
BAXTER HEALTHCARE CORPORATION
deerfield IL
Manufacturer (Section G)
BAXTER HEALTHCARE - BROOKLYN PARK
7601 northland drive
n suite 170
minneapolis MN 55428
Manufacturer Contact
25212 w. illinois route 120
round lake, IL 60073
2242702068
MDR Report Key11095153
MDR Text Key224360618
Report Number1416980-2020-08185
Device Sequence Number1
Product Code KDI
Combination Product (y/n)Y
Reporter Country CodeUS
PMA/PMN Number
K190910
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation
Type of Report Initial,Followup
Report Date 02/09/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/30/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Catalogue Number955626
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received02/08/2021
Was Device Evaluated by Manufacturer? Yes
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse

Patient Treatment Data
Date Received: 12/30/2020 Patient Sequence Number: 1
Treatment
AUTO EFFLUENT SET; EFFLUENT BAG; PRISMAFLEX M100 SET; PRISMASOL; THERMAX POUCH
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