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

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).

• Brand Name: THERMAX ON PRISMAX CRRT MACHINE
• Type of Device: DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM
• Manufacturer (Section D): BAXTER HEALTHCARE CORPORATION
• MDR Report Key: 13543703
• MDR Text Key: 285759387
• Report Number: MW5107501
• Device Sequence Number: 1
• Product Code: KDI
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 02/12/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 02/15/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: PRISMAX 109570, (B)(6) 2022-(B)(6) 2022
• Patient Age: 32 YR
• Patient Sex: Male
• Patient Weight: 64 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White