MAUDE Adverse Event Report: MAQUET ECMO OXYGENATOR

Model Number QUADROX D

Device Problem Insufficient Information (3190)

Patient Problem No Code Available (3191)

Event Date 06/06/2014

Event Type  malfunction  

Event Description

Patient undergoing open heart coronary artery bypass and aortic valve repair/replacement.Decompensated requiring ecmo.

• Brand Name: ECMO OXYGENATOR
• Type of Device: ECMO OXYGENATOR
• Manufacturer (Section D): MAQUET; wayne 07470
• MDR Report Key: 3877445
• MDR Text Key: 4588867
• Report Number: MW5036634
• Device Sequence Number: 1
• Product Code: DTZ
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 06/11/2014

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 Expiration Date: 10/31/2015
• Device Model Number: QUADROX D
• Device Lot Number: 70095119
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 06/12/2014
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 67 YR
• Patient Weight: 103