MAUDE Adverse Event Report: MEDTRONIC PERFUSION SYSTEMS MEDTRONIC AFFINITY; RESERVOIR, BLOOD, CARDIOPULMONARY BYPASS

Catalog Number 215858087

Device Problem Defective Component (2292)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 11/01/2018

Event Type  malfunction  

Event Description

It was reported there a quality issue with an integrated positive pressure relief valve on my venous reservoir.When initiating cardiopulmonary bypass, the negative venous pressure did not correlate with the vacuum assist regulator pressure.I traced all of my lines and made sure all of my connections were secure.I had other perfusionists come in the room to help me troubleshoot the issue and we found that the integrated positive pressure relief valve was faulty.During closing the surgical site, that positive pressure valve had been sucked into the venous reservoir and was on the back side of the filter screen (still in the reservoir).

• Brand Name: MEDTRONIC AFFINITY
• Type of Device: RESERVOIR, BLOOD, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): MEDTRONIC PERFUSION SYSTEMS
• MDR Report Key: 8046306
• MDR Text Key: 126964160
• Report Number: MW5081125
• Device Sequence Number: 1
• Product Code: DTN
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Attorney
• Type of Report: Initial
• Report Date: 11/05/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/06/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 215858087
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• 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