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U.S. Department of Health and Human Services

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

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BAXTER HEALTHCARE CORPORATION PRISMAX CONTROL UNIT DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM Back to Search Results
Catalog Number 955626
Device Problem Protective Measures Problem (3015)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 12/06/2021
Event Type  malfunction  
Manufacturer Narrative
Age at time of event: pediatric patient. Should additional relevant information become available, a supplemental report will be submitted.
 
Event Description
It was reported that during continuous renal replacement therapy (crrt) with a prismax machine v. 2, the preset fluid loss/gain limit of 150 changed by itself to 400g/3h. No excessive fluid removal was reported as it was only the set alarm limit that had changed. There was no patient injury or medical intervention associated with this event. No additional information is available.
 
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Brand NamePRISMAX CONTROL UNIT
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 Key13121572
MDR Text Key287031340
Report Number3003504604-2021-00010
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,Followup
Report Date 03/21/2022
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received12/30/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number955626
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer12/10/2021
Is the Reporter a Health Professional? Yes
Date Manufacturer Received02/21/2022
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 Unkown

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