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

Model Number MCH-1000

Device Problem Device Displays Incorrect Message (2591)

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

Event Date 06/21/2018

Event Type  malfunction  

Event Description

Cardioquip heater/cooler unit for cardiopulmonary bypass began to alarm.Gave "temp " error alarm.Attempted to reset, unable to do so switched out unit.Called company, tech being dispatched.

• Brand Name: MCH-1000
• Type of Device: CONTROLLER, TEMPERATURE, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): CARDIOQUIP, LP; 3827 old college rd; bryan TX 77801
• MDR Report Key: 7658377
• MDR Text Key: 113023207
• Report Number: 7658377
• 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: 06/26/2018

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: No Information
• Device Model Number: MCH-1000
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 06/26/2018
• Event Location: Operating Room
• Date Report to Manufacturer: 07/03/2018
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 07/03/2018
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 17155 DA