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

Catalog Number 955515

Device Problems Insufficient Heating (1287); Protective Measures Problem (3015)

Patient Problems Bradycardia (1751); Hypothermia (1915)

Event Date 01/28/2024

Event Type  Injury  

Event Description

It was reported the thermax blood warmer unit alarmed t2284 (thermax disposable not inserted).During continuous renal replacement therapy with a prismax machine the red wrench light illuminated on the thermax blood warmer.The nurse troubleshooted by powering the thermax ¿off and on¿.This cleared the error; however, the machine would not heat up.There was a ¿slight drop in the patient¿s¿ heart rate¿ (rate not reported) and the patient¿s temperature was abnormally low (no temperature reported).A few minutes later, the red wrench light (alarm triggered) illuminated again and this time the alarm could not be cleared.Treatment was terminated and the extracorporeal blood was returned to the patient.There was no report of medical intervention associated with this event.No further information was available at the time of this report.

Manufacturer Narrative

Should additional relevant information become available, a supplemental report will be submitted.

• Brand Name: THERMAX BLOOD WARMER UNIT
• Type of Device: DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM
• Manufacturer (Section D): BAXTER HEALTHCARE CORPORATION; deerfield IL
• Manufacturer (Section G): BAXTER HEALTHCARE - BROOKLYN PARK; 7601 northland drive; n suite 170; minneapolis MN 55428
• Manufacturer Contact: 25212 w. illinois route 120; round lake, IL 60073 ; 2242702068
• MDR Report Key: 18779001
• MDR Text Key: 336226059
• Report Number: 3003504604-2024-00003
• Device Sequence Number: 1
• Product Code: KDI
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: NA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial
• Report Date: 02/26/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 955515
• Device Lot Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/29/2024
• Initial Date FDA Received: 02/26/2024
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Treatment: PRISMAX MACHINE
• Patient Outcome(s): Other