MAUDE Adverse Event Report: ZOLL CIRCULATION ZOLL IVTM THERMOGARD XP; THERMAL REGULATING SYSTEM

Model Number 8700-0650

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  

Manufacturer Narrative

The customer reported that the thermogard xp ivtm system ((b)(6)) generated an "air trap" alarm following saline leakage from the start-up kit (suk) into the thermogard console's pump raceway.The reported complaint that accumulation of saline into the roller pump raceway rendered the thermogard system inoperable was confirmed during functional testing.During the inspection and functional testing by zoll, dried saline was noted in the roller pump raceway due to the leaking suk.The significant accumulation of dried saline in the raceway resulted in corrosive damage to the pump 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.The thermogard console needs to be returned to the zoll san jose service depot for further evaluation and service.Per ivtm intravascular temperature management operation manual, "in the event of an air trap alarm.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." during visual inspection, it was noted that one of the console's caster wheels had fallen off, unrelated to the reported complaint.This observation was most likely attributed to user handling.The wheel caster assembly was replaced to address the issue.The thermogard system's data logs were not downloaded due to the multiple technical issues with the thermogard console.Functional testing failed because the pump rotor was rusted to the motor shaft.The hall sensor board in the pump raceway did not detect that the raceway lid was open due to the corrosive damage to the pump rotor and raceway, also caused by the reported significant saline leakage.The pump rotor could not be removed from the pump motor shaft due to the excessive saline spillage and rust.The on-site service personnel drained and replaced the coolant and prepared the console to be returned to zoll san jose service depot.A follow-up report will be filed if and when the thermogard console is returned, after further evaluation and repairs have been completed.

Event Description

Approximately one hour into the cooling phase of an ivtm therapy, the thermogard xp ivtm system (sn (b)(6)) generated an "air trap" alarm.The pump rotor stopped, and the console went into standby mode.The customer noticed saline solution was leaking from the start-up kit (suk) into the roller pump area of the thermogard console.Upon further inspection, a skive cut in suk tubing at the pump roller area was observed.Due to the accumulation of saline in the roller pump raceway, the thermogard console became inoperable.The ivtm therapy was discontinued, and temperature management therapy was continued with a surface cooling device.No consequences or impacts on the patient.

Manufacturer Narrative

H6 codes were updated.The customer's biomed leadership is moving forward with the trade-in of their thermogard xp ivtm system sn (b)(6) for a new thermogard tghq console.Therefore, the thermogard console in the complaint will not be returned to zoll san jose service depot for further evaluation and service.

• Brand Name: ZOLL IVTM THERMOGARD XP
• 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: kim thoa sackrison ; 2000 ringwood ave.; san jose 95131 ; 4084192922
• MDR Report Key: 19005567
• MDR Text Key: 338930770
• Report Number: 3010617000-2024-00276
• Device Sequence Number: 1
• Product Code: NCX
• UDI-Device Identifier: 00849111075022
• UDI-Public: 00849111075022
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K072234
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Company Representative
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date: 05/31/2024

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: 8700-0650
• Device Catalogue Number: 8700-0650
• 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
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 06/01/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/01/2018
• 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