MAUDE Adverse Event Report: CARDIOQUIP LLP CARDIOQUIP MCH-1000(I) COOLER HEATER; CONTROLLER, TEMPERATURE, CARDIOPULMONARY BYPASS

Model Number MCH-1000(I)

Device Problems No Audible Alarm (1019); Device Emits Odor (1425); Smoking (1585)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 10/28/2020

Event Type  malfunction  

Event Description

During quarterly disinfection of cardioquip modular cooler heater (mch), the mch began smoking and emitting a burning smell.No audible alarms or warning indicators occurred.According to the service manual, "if the water level in the mch cold water tank falls below a safe operating level, the mch halts its operation, the low water level screen appears, and the alarm sounds a three-beep sequence every 8 seconds." this alarm was not triggered and did not occur.Fda safety report id# (b)(4).

• Brand Name: CARDIOQUIP MCH-1000(I) COOLER HEATER
• Type of Device: CONTROLLER, TEMPERATURE, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): CARDIOQUIP LLP; college station TX 77845
• MDR Report Key: 10784892
• MDR Text Key: 214776835
• Report Number: MW5097623
• Device Sequence Number: 1
• Product Code: DWC
• 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: 10/30/2020

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: MCH-1000(I)
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 11/03/2020
• 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): Other