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

Model Number PTC-1200

Device Problem Use of Device Problem (1670)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 06/25/2015

Event Type  malfunction  

Event Description

On (b)(6) 2015, the thermacor 1200 infusion system was being used at (b)(6) medical center in (b)(6).The hospital reported experiencing "limited flows" from the patient line, which resulted in leakage.The thermacor 1200 unit (1440-00062) was returned for testing, and the unit was working within specifications.The cassette and patient line were not returned for further investigation.However, the sales rep in serviced the hospital staff and observed the types of catheters being used for surgery.It was noted that the hospital was using two types of catheters - 24-27 gauge catheters.A sample cassette was returned to medical solutions, inc.Along with two catheters.Pressure increase was verified while using the smaller catheters; however, no leakage occured.Recommendations were provided to the hospital based on the findings.The smaller catheter sizes used will significantly restrict the maximum achievable flow rate and using a larger size is recommended.The user selected pressure and fluid being delivered will also impact flow rate.No patient injury was recorded.

Manufacturer Narrative

(b)(4).

• Brand Name: SMISSON-CARTLEDGE BIOMEDICAL, LLC
• Type of Device: THERMACOR 1200 INFUSION SYSTEM
• Manufacturer (Section D): SMISSON-CARTLEDGE BIOMEDICAL LLC; macon GA 31201
• Manufacturer Contact: 487 cherry street; thrid street tower; macon, GA 31201 ; 4787449992
• MDR Report Key: 4934725
• MDR Text Key: 6040183
• Report Number: 3006158088-2015-00003
• Device Sequence Number: 1
• Product Code: LGZ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K052055
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Distributor
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 06/30/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/21/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: PTC-1200
• Device Catalogue Number: PTC-1200
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/30/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1