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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 955558
Device Problem Improper or Incorrect Procedure or Method (2017)
Patient Problem Blood Loss (2597)
Event Date 06/30/2020
Event Type  Injury  
Manufacturer Narrative
(b)(6). The control unit was not received for evaluation. The event history log review identified that the cause of the event was due to use error when programming the treatment prescription. A batch review was conducted and there were no deviations found related to this reported condition during the manufacture of this lot. Use errors and proper instructions are address on the display of the prismax monitor during setup. Should additional relevant information become available, a supplemental report will be submitted.
 
Event Description
This is a case report received on the (b)(6) 2020 by baxter (b)(6) from the health facility (b)(6). Reportedly, during adjustment of flow ratios at prismax machine the pre-blood pump (pbp) and patient fluid removal rate (pfr) were confused. This caused that the settings which were set for pbp, were set for patient withdrawal. No symptoms. No further patient or treatment related data was provided. Additional information received on the 19th of january 2021: the patient was given an additional 2 erythrocyte concentrates and the fluid withdrawal at the prismax was temporarily discontinued. The patient stabilized very quickly.
 
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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 Key11261141
MDR Text Key229812180
Report Number1416980-2021-00292
Device Sequence Number1
Product Code KDI
Combination Product (y/n)Y
Reporter Country CodeSZ
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation Other Health Care Professional
Remedial Action Notification
Type of Report Initial,Followup
Report Date 02/03/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/01/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
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 Received02/02/2021
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
Removal/Correction NumberFA-2020-064

Patient Treatment Data
Date Received: 02/01/2021 Patient Sequence Number: 1
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