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U.S. Department of Health and Human Services

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

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BAXTER HEALTHCARE CORPORATION PRISMAX MACHINES 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); Tachycardia (2095)
Event Date 04/25/2022
Event Type  Injury  
Manufacturer Narrative
Initial reporter address: (b)(6). Should additional relevant information become available, a supplemental report will be submitted.
 
Event Description
It was reported that during continuous renal replacement therapy on a prismax machine, the operator erroneously programmed the patient fluid removal rate (pfr) as the flow rate prescribed for the dialysate flow rate (dfr). The patient fluid removal rate was inadvertently set to 1500 ml/hr instead of 50 ml/hr. The error was identified after four hours into treatment and the patient became hypotensive and tachycardic. The effective ultrafiltration volume removed from the patient was approximately 6l over a four hour period (1500 ml/hr x 4). The error was corrected and the patient was treated with multiple vasoactive medications, sodium and calcium (intravenously), saline (1000 ml), lactated ringer (250 ml) and albumin. No additional information is available.
 
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Brand NamePRISMAX MACHINES
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 
2242702068
MDR Report Key14461351
MDR Text Key294770865
Report Number3003504604-2022-00014
Device Sequence Number1
Product Code KDI
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K190910
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Health Professional,Company Representative
Reporter Occupation
Type of Report Initial,Followup
Report Date 07/06/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/20/2022
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
Date Manufacturer Received06/24/2022
Was Device Evaluated by Manufacturer? No
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: 05/20/2022 Patient Sequence Number: 1
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