MAUDE Adverse Event Report: CARDIOQUIP LLC CARDIOQUIP MODULAR COOLER-HEATER CONTROLLER, TEMPERATURE, CARDIOPULMONARY BYPASS

Model Number MCH-1000

Device Problems Device Emits Odor (1425); Smoking (1585)

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

Event Date 02/13/2020

Event Type  malfunction  

Event Description

Healthcare provider smelled "burning" and noted smoke coming from the heater/cooler component of the ecmo machine. Fda safety report id# (b)(4).

• Brand Name: CARDIOQUIP MODULAR COOLER-HEATER
• Type of Device: CONTROLLER, TEMPERATURE, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): CARDIOQUIP LLC
• MDR Report Key: 9763921
• MDR Text Key: 181719694
• Report Number: MW5093338
• Device Sequence Number: 1
• Product Code: DWC
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 02/24/2020

1 Device was Involved in the Event

0 Patients were Involved in the Event:

• Date FDA Received: 02/26/2020
• Is this a Product Problem Report?: Yes

Device Operator

• Device Model Number: MCH-1000
• Device Lot Number: 6/19
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/18/2020
• Is the Reporter a Health Professional?: Yes

Was the Report Sent to FDA?

• Event Location: No Information

Was Device Evaluated by Manufacturer?

Is the Device Single Use?

Is This a Reprocessed and Reused Single-Use Device?

Type of Device Usage