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

Model Number MCH-1000

Device Problem Defective Device (2588)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/10/2019

Event Type  malfunction  

Event Description

Heater cooler malfunction: there are two sensors that measure the temperature gradient.If it senses a gradient of greater than 2 degrees, it sends a temperature fault error.Patient was placed on another heater cooler.There was no patient injury.Equipment was placed out of service and sent to hospital biomed.This is the second event of this type reported from this facility.The other event was 15 months prior.

• Brand Name: CARDIOQUIP
• Type of Device: CONTROLLER, TEMPERATURE, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): CARDIOQUIP LLC; 3827 old college road; bryan TX 77801
• MDR Report Key: 8273154
• MDR Text Key: 133966687
• Report Number: 8273154
• 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: Risk Manager
• Type of Report: Initial
• Report Date: 01/21/2019

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: Other
• Device Model Number: MCH-1000
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 01/21/2019
• Device Age: 1 YR
• Event Location: Hospital
• Date Report to Manufacturer: 01/24/2019
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 01/24/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 14965 DA