MAUDE Adverse Event Report: CINCINNATI SUB-ZERO PRODUCTS, LLC / GENTHERM MEDICAL LLC HEMOTHERM HEATER / COOLER - DUAL RESERVOIR; CONTROLLER TEMPERATURE CARDIOPULMONARY BYPASS

Model Number 400CE

Device Problems Break (1069); Smoking (1585)

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

Event Date 03/26/2019

Event Type  malfunction  

Event Description

During a cardiothoracic surgical procedure, the hemotherm, a heating / cooling device with hoses that connect to the warming blanket which is under the pt, was noted to be "smoking" from the front of the machine by the perfusionist.The device was immediately unplugged, disconnected from the warming blanket and removed from the surgery room.Biomedical engineering services found the "mother board" component within the hemotherm console to have been damaged.

• Brand Name: HEMOTHERM HEATER / COOLER - DUAL RESERVOIR
• Type of Device: CONTROLLER TEMPERATURE CARDIOPULMONARY BYPASS
• Manufacturer (Section D): CINCINNATI SUB-ZERO PRODUCTS, LLC / GENTHERM MEDICAL LLC; 12011 mosteller rd.; cincinnati OH 45241
• MDR Report Key: 8515266
• MDR Text Key: 142133927
• Report Number: MW5085864
• Device Sequence Number: 1
• Product Code: DWC
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 04/03/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/12/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 400CE
• Device Catalogue Number: 86022
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/03/2019
• Is the Reporter a Health Professional?: Yes
• 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 Age: 53 YR