MAUDE Adverse Event Report: CARDIOQUIP LLP; CONTROLLER, TEMPERATURE, CARDIOPULMONARY BYPASS

Model Number MCH-1000(M)

Device Problem Therapeutic or Diagnostic Output Failure (3023)

Patient Problem Alteration In Body Temperature (2682)

Event Date 07/20/2020

Event Type  malfunction  

Event Description

The extracorporeal membrane oxygenation (ecmo) heater clicked into test mode during cannulation.Water was added and seemed to be functioning appropriately at that time.About an hour later, it was noted that the heater temperature was 30 degrees celsius and the patient's temperature decreased.The heater was exchanged with another and sent to our biomedical engineering team to investigate.

• Type of Device: CONTROLLER, TEMPERATURE, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): CARDIOQUIP LLP; 3827 old college rd; bryan TX 77801
• MDR Report Key: 10407091
• MDR Text Key: 202931073
• Report Number: 10407091
• 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: 07/24/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/14/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: MCH-1000(M)
• 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: 07/24/2020
• Event Location: Hospital
• Date Report to Manufacturer: 08/14/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other