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

Model Number TP700

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Partial thickness (Second Degree) Burn (2694)

Event Date 04/25/2022

Event Type  Injury  

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 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
• Type of Device: 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
• MDR Text Key: 292706810
• Report Number: 3015489752-2022-00001
• Device Sequence Number: 1
• Product Code: ILO
• UDI-Device Identifier: 07613327169249
• UDI-Public: 07613327169249
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K073675
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Other Health Care Professional
• Remedial Action: Inspection
• Type of Report: Initial
• Report Date: 05/25/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/25/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: 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
• Date Manufacturer Received: 05/04/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/24/2015
• 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
• Patient Outcome(s): Required Intervention