MAUDE Adverse Event Report: SMISSON-CARTLEDGE BIOMEDICAL, LLC THERMACOR 1200 INFUSION SYSTEM; PUMP, INFUSION

Model Number	PTC-1200
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	07/26/2020
Type of Reportable Event	Malfunction
Event or Problem Description
Setting up the belmont for rapid transfusion of blood products, the cassette appeared to be cracked and leaked saline and was unusable.

• Brand Name: THERMACOR 1200 INFUSION SYSTEM
• Common Device Name: PUMP, INFUSION
• Manufacturer (Section D): SMISSON-CARTLEDGE BIOMEDICAL, LLC; 487cherry st #3; macon GA 31201
• MDR Report Key: 10436124
• Report Number: 10436124
• Device Sequence Number: 2709401
• Product Code: FRN
• UDI-Device Identifier: 00857893006059
• UDI-Public: (01)00857893006059
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date (Section B): 07/29/2020
• Report Date (Section F): 07/29/2020

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
• Operator of Device: Health Professional
• Device Model Number: PTC-1200
• Device Catalogue Number: PTC-1200
• Device Lot Number: 316294
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 08/21/2020
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 08/21/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Date Report Sent to FDA: 07/29/2020