MAUDE Adverse Event Report: BAXTER HEALTHCARE CORPORATION THERMAXTHERMAX BLOOD WARMER; DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM

Model Number 955630

Device Problems Material Twisted/Bent (2981); Pressure Problem (3012); Unexpected Shutdown (4019)

Patient Problem Insufficient Information (4580)

Event Date 03/17/2021

Event Type  malfunction  

Event Description

In spring 2021, a thermax blood warmer, component of a prismax continuous renal replacement therapy, had an produced error code 'thermax malfunction' (code t2292) while in patient use, causing the machine to shut down.It resulted from a pressure issue in the line exiting the top of the dialyzer cartridge, meaning that the line was kinked.The most likely reason for this is that when the line from the dialyzer was connected to the warmer cartridge it was done in such a way that twisted it, so that when the line warmed up and became softer it collapsed and kinked.Since this machine was still covered under warranty agreement due to recent purchase, a manufacturer field tech was dispatched to our site and verified proper operation of the machine by running two consecutive patient simulations, after which the service report was uploaded to our asset master and the machine was returned to service.

• Brand Name: THERMAXTHERMAX BLOOD WARMER
• Type of Device: DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM
• Manufacturer (Section D): BAXTER HEALTHCARE CORPORATION; one baxter parkway; deerfield IL 60015
• MDR Report Key: 11693255
• MDR Text Key: 246274440
• Report Number: 11693255
• Device Sequence Number: 1
• Product Code: KDI
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 03/29/2021

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: No Information
• Device Model Number: 955630
• Device Catalogue Number: 955630
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 03/29/2021
• Device Age: 10 MO
• Event Location: Hospital
• Date Report to Manufacturer: 04/20/2021
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 04/20/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 19345 DA