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

Model Number	PTC-1200
Medical Device Problem Codes	Fluid/Blood Leak (1250); Leak/Splash (1354); Mechanical Problem (1384)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	02/28/2020
Type of Reportable Event	Malfunction
Event or Problem Description
The thermacor 1200 infusion system was used at (b)(6) on (b)(6) 2020.During surgery, the hospital reported the cassette patient line connector detached from the cassette patient line tubing and blood spilled from the line.The cassette and patient line were replaced, and the surgery was completed.No patient injury or extended time to surgery was noted due to the changing of the cassette and patient line.The cassette and patient line were returned to (b)(4) (distributor).The complaint was confirmed.Retains from lot 315515 were also reviewed; no issue was noted with the retains (cassette and patient line).Pictures of the defective cassette and patient line were forwarded to the manufacturer, ethox medical.Ethox medical investigated the complaint.Ethox medical reviewed the dhr file for this lot; no issue was noted.Ethox performed pull tests on the pvc tubing with and without solvent applied to the bond.No difference was noted between the two test samples.According to ethox, the tensile test performed show that it would take a significant amount of force to separate the components with or without solvent applied, and the pvc tube would delaminate/tear prior to the two components separating.Results were inconclusive as to how this happened.No other issues have been noted from the field for this type of complaint on this lot or any other lot.Thermacor 1200 infusion pump, (b)(4) , was also returned for testing.The unit performed as intended.No issue was noted with the unit; the unit was returned to the hospital.
Additional Manufacturer Narrative
Corrected retain lot number in section a5.Original submission indicated retains reviewed for lot 315515, and it should have been lot 314412.
Event or Problem Description
The thermacor 1200 infusion system was used at (b)(6) in (b)(6) on (b)(6) 2020.During surgery, the hospital reported the cassette patient line connector detached from the cassette patient line tubing and blood spilled from the line.The cassette and patient line were replaced, and the surgery was completed.No patient injury or extended time to surgery was noted due to the changing of the cassette and patient line.The cassette and patient line were returned to medical solutions, inc (smisson-cartledge biomedical distributor).The complaint was confirmed.Retains from lot 314412* were also reviewed; no issue was noted with the retains (cassette and patient line).Pictures of the defective cassette and patient line were forwarded to the manufacturer, (b)(6).(b)(6) investigated the complaint.(b)(6) reviewed the dhr file for this lot; no issue was noted.(b)(6) performed pull tests on the pvc tubing with and without solvent applied to the bond.No difference was noted between the two test samples.According to (b)(6), the tensile test performed show that it would take a significant amount of force to separate the components with or without solvent applied, and the pvc tube would delaminate/tear prior to the two components separating.Results were inconclusive as to how this happened.No other issues have been noted from the field for this type of complaint on this lot or any other lot.Thermacor 1200 infusion pump, 1849-00070, was also returned for testing.The unit performed as intended.No issue was noted with the unit; the unit was returned to the hospital.*retain lot number was corrected to lot 314412.

• 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 tower, 3rd floor; macon, ga
• MDR Report Key: 9890807
• Report Number: 3006158088-2020-00002
• Device Sequence Number: 11212636
• Product Code: FRN
• UDI-Device Identifier: 00857893006059
• UDI-Public: (01)00857893006059(10)314412(11)180622(17)230622
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K052055
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/03/2020

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 Expiration Date: 06/22/2023
• Device Model Number: PTC-1200
• Device Catalogue Number: PTC-1200
• Device Lot Number: 314412
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/28/2020
• Initial Date Received by Manufacturer: 03/03/2020
• Supplement Date Received by Manufacturer: 03/03/2020
• Initial Report FDA Received Date: 03/27/2020
• Supplement Report FDA Received Date: 04/02/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1