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U.S. Department of Health and Human Services

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

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BAXTER HEALTHCARE CORPORATION THERMAX ON PRISMAX CRRT MACHINE DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM Back to Search Results
Device Problems Thermal Decomposition of Device (1071); Material Discolored (1170); Moisture Damage (1405)
Patient Problem Insufficient Information (4580)
Event Date 02/11/2022
Event Type  malfunction  
Event Description
The prismax crrt machine circuit was being changed after expiration. Upon removal of thermax blood warmer, bottom of tubing noted to be burned and moisture noted on metal heating element. Metal heating element also appeared discolored. Fda safety report id# (b)(4).
 
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Brand NameTHERMAX ON PRISMAX CRRT MACHINE
Type of DeviceDIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM
Manufacturer (Section D)
BAXTER HEALTHCARE CORPORATION
MDR Report Key13543703
MDR Text Key285759387
Report NumberMW5107501
Device Sequence Number1
Product Code KDI
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation
Type of Report Initial
Report Date 02/12/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/15/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Is This a Reprocessed and Reused Single-Use Device? No

Patient Treatment Data
Date Received: 02/15/2022 Patient Sequence Number: 1
Treatment
PRISMAX 109570, (B)(6) 2022-(B)(6) 2022
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