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U.S. Department of Health and Human Services

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

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BAXTER HEALTHCARE - BROOKLYN PARK PRISMAX DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM Back to Search Results
Catalog Number 955558
Device Problem Improper or Incorrect Procedure or Method (2017)
Patient Problem Hypovolemia (2243)
Event Date 07/23/2019
Event Type  malfunction  
Manufacturer Narrative
A device history review revealed no issues that could have caused or contributed to the reported issue. The event history log was reviewed and identified the cause of the event was due to use error. Use errors and proper instructions are address on the display of the prismax monitor during setup. When prescribing the flow rates for therapy, pfr (patient fluid removal) is listed and effluent dose is listed below. The abbreviation help screen defines pfr and explains the calculation for patient fluid removal. Before entering treatment, the operator is instructed to review the prescription. The patient fluid removal rate is listed and not abbreviated on the screen. Additional instructions are in the prismax operator¿s manual, which is provided with every prismax monitor. The guide instructs the user to prescribe and monitor patient fluid removal to avoid errors in patient fluid balance. It also lists warnings, cautions, and instructions for monitoring the patient fluid removal during therapy. Should additional relevant information become available, a supplemental report will be submitted.
 
Event Description
It was reported that the patient sustained 1200ml excessive fluid removal while undergoing treatment with a prismax dialysis machine. When programming the prescription, the operator accidentally interpreted the patient fluid removal rate (pfr) in the graphical user interphase as hourly postdilution replacement volume and set the pfr to 1200 ml when it should have been set to zero. No further patient or treatment related data was provided. 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 - BROOKLYN PARK
minneapolis MN
Manufacturer (Section G)
BAXTER HEALTHCARE - BROOKLYN PARK
7601 northland drive
suite 170
minneapolis MN 55428
Manufacturer Contact
25212 w. illinois route 120
round lake, IL 60073
2242702068
MDR Report Key8907480
MDR Text Key197097941
Report Number3003504604-2019-00005
Device Sequence Number1
Product Code KDI
Combination Product (y/n)N
Reporter Country CodeSZ
PMA/PMN Number
NI
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 08/19/2019
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received08/19/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number955558
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 Received07/24/2019
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

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