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U.S. Department of Health and Human Services

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

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BAXTER HEALTHCARE CORPORATION PRISMAX SYSTEM DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM Back to Search Results
Model Number 955626
Device Problems Device Displays Incorrect Message (2591); Unexpected Shutdown (4019)
Patient Problem Insufficient Information (4580)
Event Date 01/21/2021
Event Type  malfunction  
Event Description
Machine was running normally during treatment when it shut off for 35 to 40 seconds and alarmed. The screen turned red and was unable to return the blood to the patient. The "call service" screen with steps on how to manually return the blood and to call service did not appear. Field service engineer (fse) was unable to duplicate the error. Log files were obtained and forwarded to specialist for further investigation. Fse performed scales, motors, power board, and safety board self-service tests, and all passed. The fse also ran prime and extended patient simulation to verify operation of device.
 
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Brand NamePRISMAX SYSTEM
Type of DeviceDIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM
Manufacturer (Section D)
BAXTER HEALTHCARE CORPORATION
one baxter parkway
deerfield IL 60015
MDR Report Key11272022
MDR Text Key230110353
Report Number11272022
Device Sequence Number1
Product Code KDI
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source User Facility
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 01/27/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received02/03/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number955626
Device Catalogue Number955626
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer01/22/2021
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? Yes
Date Report Sent to FDA01/27/2021
Device Age1 YR
Event Location Hospital
Date Report to Manufacturer02/03/2021
Was Device Evaluated by Manufacturer? No Answer Provided
Is the Device Single Use? No Answer Provided
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unkown

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