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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 955558
Device Problem No Visual Prompts/Feedback (4021)
Patient Problem Blood Loss (2597)
Event Date 12/05/2020
Event Type  Injury  
Manufacturer Narrative
Should additional relevant information become available, a supplemental report will be submitted.
 
Event Description
It was reported that during continuous renal replacement therapy using a prismax control unit, the device ¿froze¿ during blood return. Treatment was ended without the extracorporeal blood being returned to the patient. Blood loss of 180 ml was reported. It was reported the patient required a blood transfusion (no further details). At the time of this report, the patient outcome was not reported. 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
brooklyn park MN 55428
Manufacturer Contact
25212 w. illinois route 120
round lake, IL 60073
2242702068
MDR Report Key11087628
MDR Text Key224073616
Report Number1416980-2020-08126
Device Sequence Number1
Product Code KDI
Combination Product (y/n)Y
Reporter Country CodeAS
PMA/PMN Number
K190910
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation
Type of Report Initial,Followup
Report Date 03/05/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/29/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number955558
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received02/24/2021
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: 12/29/2020 Patient Sequence Number: 1
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