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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 Problem Low Blood Pressure/ Hypotension (1914)
Event Date 11/16/2020
Event Type  Injury  
Manufacturer Narrative
Should additional relevant information become available, a supplemental report will be submitted.
 
Event Description
It was reported that an excessive fluid removal occurred during continuous renal replacement therapy while using a prismax for the first time in the facility. Instead of entering a patient fluid removal (pfr) of 110 ml/hour the nurse set the total replacement of 1400 ml as pfr. The patient became hypotensive and norepinephrine infusion was titrated up to improve the patient 's blood pressure (bp). The physician was notified and the pfr was then set to zero since over 900 ml had been removed from the patient. The patient was drowsy but remained alert and oriented and on nasal cannula oxygen. The bp improved with pfr set at zero and increased norepinephrine dose. 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 Key10976943
MDR Text Key220472863
Report Number1416980-2020-07653
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 Other Health Care Professional
Type of Report Initial,Followup,Followup
Report Date 03/23/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/09/2020
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? No
Distributor Facility Aware Date11/16/2020
Event Location Hospital
Date Manufacturer Received03/18/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
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: 12/09/2020 Patient Sequence Number: 1
Treatment
AUTO EFFLUENT SET; PRISMAFLEX M150; PRISMASOL 2K/3.5CA; THERMAX POUCH
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