MAUDE Adverse Event Report: MAQUET CARDIOVASCULAR QUADROX-I; OXYGENATOR, CARDIOPULMONARY BYPASS

Lot Number 92198238

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

Patient Problem Air Embolism (1697)

Event Date 04/21/2015

Event Type  No Answer Provided  

Event Description

Patient was cross clamped on coronary bypass when air was noted in the patient's brain by neuromonitoring and air was noted in the patient's aorta via echocardiogram.No air was detected by the maquet oxygenator or centrifugal pump.

• Brand Name: QUADROX-I
• Type of Device: OXYGENATOR, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): MAQUET CARDIOVASCULAR; 45 barbour pond drive; wayne NJ 07470
• MDR Report Key: 4814569
• MDR Text Key: 5892950
• Report Number: 4814569
• Device Sequence Number: 1
• Product Code: DTZ
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 05/22/2015

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?: *
• Device Operator: Invalid Data
• Device Lot Number: 92198238
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 05/22/2015
• Event Location: Hospital
• Date Report to Manufacturer: 06/03/2015
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 05/22/2015
• Patient Sequence Number: 1
• Treatment: PATIENT ON CORONARY BYPASS
• Patient Age: 5 YR