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

Model Number	PTC-1200
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/30/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
The thermacor 1200 rapid infusion system was being used at (b)(6) medical center on (b)(6) 2024, and during a procedure, the hospital stated the return line on the 3 spike set detached and caused blood to leak at the line connection.The set was replaced and the surgery continued.No patient injury or extended time to surgery was noted by the hospital.The dhr was reviewed, and no issue was noted during assembly or during leak testing.The 3 spike set was returned by the hospital, and the investigation was completed.The returned 3 spike set connections were checked and verified to meet specifications.During the inspection, it was noted that the one-way valve that the barb is attached to was placed properly and there were no issues noted with the valve.It was installed correctly, and 15psi of air was sent through it.When air was sent in the other direction, the valve shut and blocked the air access as it should.The retain sample was tested and no issue was noted.The retain sample was opened, and the return line connection was secure.No issue has been noted for this lot of cassettes with the 3 spike sets in the field.There is no inventory left available for this lot of cassettes.It was noted that this was a user error in handling of the 3 spike set.It is very likely that the nurse/operator held onto the tube while unscrewing the luer instead of holding onto the luer's grooves to unscrew.Additional training will be conducted to ensure proper handling and usage of the cassette and 3 spike sets are performed correctly by the hospital personnel.

• Brand Name: SMISSON-CARTLEDGE BIOMEDICAL, LLC
• Common Device Name: THERMACOR 1200 INFUSION SYSTEM
• Manufacturer (Section D): SMISSON-CARTLEDGE BIOMEDICAL, LLC; 487 cherry street; third street towe, third floor; macon GA 31201
• Manufacturer (Section G): MEDISURGE; 2140 oak industrial drive ne; grand rapids MI 49505
• Manufacturer Contact: donna stevenson ; 487 cherry street; third street tower, 3rd floor; macon, GA 31201 ; 4783306205
• MDR Report Key: 20762092
• Report Number: 3006158088-2024-00001
• Device Sequence Number: 8587876
• Product Code: FRN
• UDI-Device Identifier: 00857893006110
• UDI-Public: (01)00857893006110(10)08139-060624(11)240606(17)290606
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Initial Reporter Country: US
• PMA/510(K) Number: K202461
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 11/22/2024

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
• Operator of Device: Health Professional
• Device Model Number: PTC-1200
• Device Catalogue Number: PTC-1200
• Device Lot Number: 08139-060624
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/08/2024
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/29/2024
• Initial Report FDA Received Date: 11/22/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/06/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown