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

Model Number THERMACOR 1200

Device Problems Break (1069); Inadequate Instructions for Healthcare Professional (1319); Defective Device (2588); Device Markings/Labelling Problem (2911)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/08/2019

Event Type  Death  

Event Description

Thermacor rapid infuser began to repeatedly show an error stating "overheated - turn off and on." this required constant pauses in the rapid infusing of blood products to a critical pt.It was unplugged, therefore the heating mechanism was not in use.We tried plugging the machine in so that it would not be using battery power, but the error message continued.Vendor - sent the supplies (contained older version of the filter we were not educated on (tubing / filter for new thermacor 1200).Add'l problem identified - the packaging for the tubing / filters mentioned above have the same packaging and product numbers.Equipment malfunction - clip broke off.Manual process used by staff to prevent pt harm.

Event Description

Add'l info received for report mw5090032.Caller called to update pt's condition as deceased and that the thermacor device did not contribute to the pt's death.

• Brand Name: THERMACOR 1200 THERMAL INFUSER SYSTEM
• Type of Device: WARMER, THERMAL, INFUSION FLUID
• Manufacturer (Section D): SMISSON-CARTLEDGE BIOMEDICAL, LLC; 487 cherry street; third street tower ; macon GA 31201
• MDR Report Key: 9118867
• MDR Text Key: 160228857
• Report Number: MW5090032
• Device Sequence Number: 1
• Product Code: LGZ
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 09/09/2019
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: THERMACOR 1200
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 09/24/2019
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 10/03/2019
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Death
• Patient Age: 25 YR