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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
Model Number PRISMAX V2
Device Problems Image Display Error/Artifact (1304); Application Program Freezes, Becomes Nonfunctional (4031)
Patient Problem Insufficient Information (4580)
Event Date 02/15/2021
Event Type  malfunction  
Event Description
While patient was on crrt treatment, the machine's screen froze spontaneously, and treatment was stopped. The device was removed from service and the problem was duplicated by biomed technician. When the problem was duplicated and could not be resolved, the vendor field service engineer was called for support. Vendor came in and updated the software. Once fse (field service engineer) verified proper operation, the device was returned to the floor. Manufacturer response for hemodialysis, prismax (per site reporter): field service engineer came in house to resolve the problem by upgrading software.
 
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Brand NamePRISMAX
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 Key11421178
MDR Text Key235009861
Report Number11421178
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 02/24/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received03/05/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberPRISMAX V2
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? Yes
Date Report Sent to FDA02/24/2021
Device Age1 YR
Event Location Hospital
Date Report to Manufacturer03/05/2021
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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