MAUDE Adverse Event Report: CARDIOQUIP LLC MCH-1000; CONTROLLER, TEMPERATURE, CARDIOPULMONARY BYPASS

Model Number MCH-1000

Device Problems Smoking (1585); Noise, Audible (3273); Excessive Heating (4030)

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

Event Date 08/24/2019

Event Type  malfunction  

Event Description

Patient alerted staff nurse there was a "pop" from the ecmo machine and the room smelled like smoke.The heater of the ecmo machine was extremely hot to the touch.Cardiac perfusionist called to bedside to remove the heater and replace with another one.

• Brand Name: MCH-1000
• Type of Device: CONTROLLER, TEMPERATURE, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): CARDIOQUIP LLC; 3827 old college rd; bryan TX 77801
• MDR Report Key: 9129328
• MDR Text Key: 160378346
• Report Number: 9129328
• Device Sequence Number: 1
• Product Code: DWC
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 08/27/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/27/2019
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: MCH-1000
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 08/27/2019
• Event Location: Hospital
• Date Report to Manufacturer: 09/27/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1