MAUDE Adverse Event Report: MEDTRONIC FUSION OXYGENATOR

Model Number OPEN HEART PACK

Device Problem Fluid/Blood Leak (1250)

Patient Problem Blood Loss (2597)

Event Date 10/17/2017

Event Type  Injury  

Event Description

Upon initiation of cardiopulmonary bypass, a small leakage of blood from the bottom of the oxygenator was noted.Bone wax placed on leak.Abg's evaluated and closely monitored.Scavenge line removed from gas outlet of oxygenator.Pump flow reduced.After placement of bone wax, blood continued to leak out of other holes but, with modifications listed, procedure was able to be completed without adverse outcome to patient.

• Brand Name: FUSION OXYGENATOR
• Type of Device: FUSION OXYGENATOR
• Manufacturer (Section D): MEDTRONIC
• MDR Report Key: 6964365
• MDR Text Key: 89958534
• Report Number: MW5072851
• Device Sequence Number: 1
• Product Code: DTZ
• Combination Product (y/n): N
• 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: 10/18/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/20/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: OPEN HEART PACK
• Device Catalogue Number: HY7S51R10
• Device Lot Number: 212274599
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• 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
• Patient Outcome(s): Required Intervention
• Patient Age: 75 YR