MAUDE Adverse Event Report: TERUMO SYSTEM 1 CARDIOPULMONARY BYPASS; CARDIAC BYPASS MACHINE

Model Number SYSTEM 1

Device Problem Occlusion Within Device (1423)

Patient Problems Death (1802); Hemorrhage/Bleeding (1888); Atrial Perforation (2511)

Event Date 08/31/2015

Event Type  Death  

Event Description

Patient undergoing redo aortic valve repair, ascending aortic aneurysm repair, and mitral valve repair.Patient came off of bypass pump, and surgeon noted a hole in the atrium.Bleeding became uncontrollable, and surgeon requested the patient to be placed back on bypass in order to repair the atrium.Unable to re-establish bypass flow due to clotting in the system.New machine and set-up to be brought in.

• Brand Name: SYSTEM 1 CARDIOPULMONARY BYPASS
• Type of Device: CARDIAC BYPASS MACHINE
• Manufacturer (Section D): TERUMO; ann arbor MI 48103
• MDR Report Key: 5077517
• MDR Text Key: 25907620
• Report Number: MW5056130
• Device Sequence Number: 1
• Product Code: DTQ
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 09/10/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/10/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: SYSTEM 1
• Is the Reporter a Health Professional?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Death
• Patient Age: 63 YR
• Patient Weight: 142