MAUDE Adverse Event Report: CARDIOQUIP LLC CARDIO QUIP MCH-1000(I); CONTROLLER, TEMPERATURE, CARDIOPULMONARY BYPASS

Model Number 12161274

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

Patient Problem Insufficient Information (4580)

Event Date 01/25/2021

Event Type  malfunction  

Event Description

Heater cooler cultured as part of heater cooler investigation process.Fda safety report id # (b)(4).

• Brand Name: CARDIO QUIP MCH-1000(I)
• Type of Device: CONTROLLER, TEMPERATURE, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): CARDIOQUIP LLC; college station TX 77845
• MDR Report Key: 11776778
• MDR Text Key: 249445121
• Report Number: MW5101170
• 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: 05/03/2021

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: 12161274
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 05/04/2021
• 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