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

Catalog Number 955515

Device Problem Device Sensing Problem (2917)

Patient Problems Bradycardia (1751); Low Blood Pressure/ Hypotension (1914); Hypothermia (1915)

Event Date 01/02/2023

Event Type  Injury  

Manufacturer Narrative

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

Event Description

It was reported the red light of the thermax blood warmer unit ¿was on and stopped warming blood¿ and the patient¿s body temperature decreased.The patient started therapy of continuous renal replacement therapy (crrt) using a prismax machine equipped with a thermax blood warmer unit one day prior to the event onset with a blood flow rate of 200ml/hour.The patient¿s body temperature was 38.6 (degrees celsius).The following day the thermax blood warmer unit stopped heating the blood even though the red light was ¿on¿.No alarms were noted that the thermax machine had stopped heating, and the prismax machine continued with crrt.The patient¿s body temperature gradually decreased to 32.0 (degrees celsius).Treatment was halted.The patient was noted to be hemodynamically unstable with a decrease in heart rate and blood pressure (bp) (values not reported).The patient required an increase in inotrope support to ensure the patient¿s bp was in normal limits, a bare hugger was applied to warm patient and a constant monitoring of the patient¿s temperature was inserted (not further described).The patient restarted therapy the following day with a different prismax and thermax machines.No additional information is available.

Manufacturer Narrative

Additional information: h3, h6 and h10.H10: the device was evaluated on site by a baxter qualified technician.The log files were reviewed.Upon review the t2295 alarmed signifying the thermax malfunction affecting heat.The operator overrode the alarm to continue treating the patient, but, as the alarm conditions were still present, the thermax disabled the heating.The prismax operator manual instructs the user that the actions overriding the thermax heating alarms interrupt the blood warming.Heating will continue only if the alarm condition is no longer present.Tap the alarm off button to continue running, this will cause the system to continue treatment with the status lightbar at a constant yellow.This is to remind the operator to closely monitor treatment during this specific override condition.In addition, the thermax operator manual warns the user of the risk of hypothermia in case the warmer cannot be started or in cases where the patient has an unacceptable temperature balance.The user is informed that alternative warming methods should be considered in order to reduce the risk of hypothermia and to promote the patient¿s comfort and well-being.Also, in the files, the alarm t2295 indicated that ¿both inlet and outlet zone power mismatch between commanded and measured¿, meaning that the thermax was no more able to control the temperature of the blood for an internal malfunction.The heater controller board was replaced to correct the issue.After which, the unit passed calibration, sst's, electrical safety tests and patient simulation.The unit ran on simulated treatment for 1/2 hour with no issues noted.The t2295 alarm was verified.The cause of the condition was due to a heater controller board requiring replacement.The temp too low was not verified.A device history review revealed no issues that could have caused or contributed to the reported issue.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: 16280078
• MDR Text Key: 308585463
• Report Number: 3003504604-2023-00005
• Device Sequence Number: 1
• Product Code: KDI
• UDI-Device Identifier: 07332414123925
• UDI-Public: (01)07332414123925(21)
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: N/A
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 03/16/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/01/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• 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?: No
• Date Manufacturer Received: 03/07/2023
• Was Device Evaluated by Manufacturer?: No
• 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): Required Intervention