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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 No Visual Prompts/Feedback (4021)
Patient Problem Blood Loss (2597)
Event Date 01/24/2020
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 experienced a locked screen. It was reported the screen ¿got frozen¿ while the nurse was checking the history, specifically "the pressures". It was reported ¿there were no graphics and the screen was blocked¿. The treatment was ended without the extracorporeal blood being returned to the patient. It was reported during a manual blood restitution there are no air bubble detection, access or return alarms. It was reported prior to the event, the patient¿s hemoglobin was 5. 0mmol/l, then decreased to 4. 4mmol/l, after the event. The patient received a concentrated erytocytes blood transfusion. It was reported ¿there were no further hemodynamic consequences¿. At the time of this report, the patient outcome was not reported. 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 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 Key9722867
MDR Text Key189331085
Report Number3003504604-2020-00001
Device Sequence Number1
Product Code KDI
Combination Product (y/n)N
Reporter Country CodeNL
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 04/08/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/18/2020
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? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received03/27/2020
Was Device Evaluated by Manufacturer? Yes
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unkown

Patient Treatment Data
Date Received: 02/18/2020 Patient Sequence Number: 1
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