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

Model Number TIS-1200

Device Problem Pressure Problem (3012)

Patient Problem No Information (3190)

Event Date 01/08/2015

Event Type  malfunction  

Event Description

The thermacor 1200 infusion system was being used at (b)(6) on (b)(6) 2015.The hospital stated two cassettes were leaking and instead of changing out another cassette the infusion pump was replaced.No pt or additional product info was available.The unit was tested by the sale rep, and he noticed that the unit did not sense pressure when the pt line was clamped.The unit ((b)(4)) was returned to the mfr for investigation.It was noted that the right housing (internal) showed damage at the pressure port area.Rough handling of loading and unloading cassettes could have possibly caused this damage.The mfr has made an improvement to the pressure port area of the pump by having the pressure port pems molded into the housing.The new style housing has been installed on this unit.Acceptance testing was performed on the unit with no problems noted.

Manufacturer Narrative

(b)(4).

• Brand Name: SMISSON-CARTLEDGE BIOMEDICAL, LLC
• Type of Device: THERMACOR 1200 INFUSION SYSTEM, LGZ AND FRN
• Manufacturer (Section D): SMISSON-CARTLEDGE BIOMEDICAL LLC; macon GA
• Manufacturer Contact: 487 cherry st; macon, GA 31201 ; 4787449992
• MDR Report Key: 4494626
• MDR Text Key: 5347517
• Report Number: 3006158088-2015-00001
• 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: 01/12/2015

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
• Device Operator: Health Professional
• Device Model Number: TIS-1200
• Device Catalogue Number: TIS-1200
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 02/02/2015
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/12/2015
• Initial Date FDA Received: 02/05/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/01/2014
• 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