MAUDE Adverse Event Report: ZOLL CIRCULATION ZOLL THERMOGARD HQTM CONSOLE; THERMAL REGULATING SYSTEM

Model Number THERMOGARD HQ

Device Problems Use of Device Problem (1670); Visual Prompts will not Clear (2281)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 03/04/2024

Event Type  malfunction  

Event Description

During the cooling phase of the ivtm therapy using the thermogard hq temp mgt console (b)(6), the start-up kit (suk) (lot #unknown) started leaking saline at the roller pump area.The thermogard hq console (b)(6) generated an air trap alert.A skive cut in suk tubing at the pump rotor was observed upon inspection.The dwell time of the suk was 2 hours.Saline in the roller-pump raceway rendered the thermogard hq console inoperable.As such, another thermogard hq console was used to continue therapy.No consequences or impacts on the patient.The customer discarded the suk and will not be returned for investigation.

Manufacturer Narrative

The customer's complaint that the thermogard hq temperature management console (b)(6) generated an air trap alert and the saline in the roller-pump raceway rendered the thermogard hq console inoperable was confirmed during the event log review and functional testing.During the inspection and functional testing by zoll, dried saline was noted in the roller pump raceway due to a leaking start-up kit (suk).The significant accumulation of dried saline in the raceway has caused corrosive damage to the rotor.The corrosive damage could have been prevented by immediately drying the raceway after the saline spillage or leak; however, in this case, it is evident that the user did not follow the instructions in the operation manual.Per thermogard hq temperature management system operation manual, with any air trap alarm, investigate to see if there is spillage into the raceway.Remove the rotor and blot dry the raceway and motor shaft to minimize the risk of corrosion or damage to the console.Unrelated to the reported complaint, a crack on the top cover was noted upon visual inspection.The top cover was replaced to address the observed physical damage.The event log review indicated the occurrence of event alarms 2.5 (alert saline empty) and 1.5 (alarm air trap warning) on and around the reported event date.After replacing the rotor, the thermogard hq console passed the power-on self-test (post) and further functional testing without issues.Following service, the thermogard hq console passed the final functional and electrical safety tests without issues.Historical complaints were reviewed for service information related to the reported complaint, and there was no previous history of complaints reported for the thermogard hq console with (b)(6).

• Brand Name: ZOLL THERMOGARD HQTM CONSOLE
• Type of Device: THERMAL REGULATING SYSTEM
• Manufacturer (Section D): ZOLL CIRCULATION; 2000 ringwood ave.; san jose CA 95131
• Manufacturer (Section G): ZOLL CIRCULATION; 2000 ringwood ave.; san jose CA 95131
• Manufacturer Contact: kimthoa sackrison ; 2000 ringwood ave.; san jose, CA 95131 ; 4084192922
• MDR Report Key: 19004211
• MDR Text Key: 339011383
• Report Number: 3010617000-2024-00295
• Device Sequence Number: 1
• Product Code: NCX
• UDI-Device Identifier: 00849111075800
• UDI-Public: 00849111075800
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K220008
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 03/29/2024

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
• Device Model Number: THERMOGARD HQ
• Device Catalogue Number: 601352-001
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/04/2024
• Initial Date FDA Received: 03/29/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/01/2022
• 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