MAUDE Adverse Event Report: PERFUSION SYSTEMS DLP AORTIC ROOT ANTEGRADE ANTEGRADE CANNULA; CATHETER, CANNULA AND TUBING, VASCULAR, CARDIOPULMONARY BYPASS

Model Number	10218
Medical Device Problem Code	Air Leak (1008)
Health Effect - Clinical Code	Death (1802)
Date of Event	04/20/2017
Type of Reportable Event	Death
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
Medtronic received information that during the delivery of cardioplegia with this cannula, the customer noted entrainment of air.The device was replaced with another cannula from the same lot, but the same issue was noted.The customer later noted the upper connection port on the cannula could easily be separated from the tip.The patient passed away one day after the case.
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.

• Brand Name: DLP AORTIC ROOT ANTEGRADE ANTEGRADE CANNULA
• Common Device Name: CATHETER, CANNULA AND TUBING, VASCULAR, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): PERFUSION SYSTEMS; 7611 northland dr; brooklyn park MN 55428
• MDR Report Key: 6586241
• Report Number: 2184009-2017-00020
• Device Sequence Number: 16242036
• Product Code: DWF
• UDI-Device Identifier: 20613994540113
• UDI-Public: 20613994540113
• Combination Product (Y/N): N
• Initial Reporter Country: SF
• PMA/510(K) Number: K040173
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 05/23/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 05/31/2019
• Device Model Number: 10218
• Device Catalogue Number: 10218
• Device Lot Number: 2016050479
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/10/2017
• Initial Date Received by Manufacturer: 04/24/2017
• Supplement Date Received by Manufacturer: Not provided; 05/23/2017
• Initial Report FDA Received Date: 05/23/2017
• Supplement Report FDA Received Date: 06/20/2017; 09/07/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Death