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

Model Number MCH-1000(I)

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Bradycardia (1751); High Blood Pressure/ Hypertension (1908)

Event Date 01/07/2021

Event Type  malfunction  

Event Description

Patient became bradycardic/hypertensive suddenly around 1430, it was found that the water heater on the ecmo circuit had been put onto standby unknowingly, upon discovering this it was restarted, patient was rewarmed slowly and bradycardia/ hypertension resolved.

• Brand Name: CARDIOQUIP MODULAR COOLER-HEATER (MCH)
• Type of Device: CONTROLLER, TEMPERATURE, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): CARDIOQUIP, LLC; 8422 calibration ct; college station TX 77845
• MDR Report Key: 11863523
• MDR Text Key: 251977020
• Report Number: 11863523
• 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: Other Health Care Professional
• Type of Report: Initial
• Report Date: 04/19/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/21/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: MCH-1000(I)
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 04/19/2021
• Event Location: Hospital
• Date Report to Manufacturer: 05/21/2021
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 30 DA
• Patient Weight: 4