MAUDE Adverse Event Report: C2DX, INC. T/PUMP PROFESSIONAL; T/PUMP, TP700

Model Number	TP700
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Partial thickness (Second Degree) Burn (2694)
Date of Event	04/25/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
On 13-may-2022, the c2dx service technician performed functional checks according to the t/pump professional maintenance manual.The flow and temperature tests were both within specification.While running maintenance manual functional checks, the service technician noticed corrosion of the brass block and identified other preventative maintenance items to be addressed before potential return to service.
Event or Problem Description
(b)(6) emailed c2dx on 5/4/2022 indicating that a burn incident had occurred at a location that agiliti health services, referred to as (b)(6) hospital.The patient was undergoing a four-hour surgery around noon on (b)(6), and the t/pump was being used.

• Brand Name: T/PUMP PROFESSIONAL
• Common Device Name: T/PUMP, TP700
• Manufacturer (Section D): C2DX, INC.; 555 e. eliza street; ste a; schoolcraft MI 49087
• Manufacturer (Section G): C2DX, INC; 555 e. eliza street; ste a; schoolcraft MI 49087
• Manufacturer Contact: ryan eggleston ; 555 e. eliza street; ste a; schoolcraft, MI 49087 ; 8889022239
• MDR Report Key: 14500587
• Report Number: 3015489752-2022-00001
• Device Sequence Number: 14892564
• Product Code: ILO
• UDI-Device Identifier: 07613327169249
• UDI-Public: 07613327169249
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K073675
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Y
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Remedial Action: Inspection
• Type of Report: Initial
• Report Date (Section B): 05/25/2022

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?: No
• Operator of Device: Health Professional
• Device Model Number: TP700
• Device Catalogue Number: TP700
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/13/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/04/2022
• Initial Report FDA Received Date: 05/25/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/24/2015
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown