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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BAXTER HEALTHCARE CORPORATION BAXTER PRISMAX. SERIAL NUMBER 109333 DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM

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BAXTER HEALTHCARE CORPORATION BAXTER PRISMAX. SERIAL NUMBER 109333 DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM Back to Search Results
Model Number PRISMAX
Device Problem Display or Visual Feedback Problem (1184)
Patient Problem Insufficient Information (4580)
Event Date 12/20/2021
Event Type  malfunction  
Event Description
Crrt machine red alarmed and entire screen turned red error message "software error heap exhausted". Bedside rn, clinical manager, and charge rn responded to alarm immediately. Baxter service representative contacted. Unable to clear error and machine had to be turned off. Hemodialysis catheter heparin locked. Fda safety report id# (b)(4).
 
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Brand NameBAXTER PRISMAX. SERIAL NUMBER 109333
Type of DeviceDIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM
Manufacturer (Section D)
BAXTER HEALTHCARE CORPORATION
MDR Report Key13111064
MDR Text Key283087426
Report NumberMW5106316
Device Sequence Number1
Product Code KDI
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation Risk Manager
Type of Report Initial
Report Date 12/23/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/28/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberPRISMAX
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes

Patient Treatment Data
Date Received: 12/28/2021 Patient Sequence Number: 1
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