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

Model Number 10218

Device Problem Air Leak (1008)

Patient Problem Death (1802)

Event Date 04/20/2017

Event Type  Death  

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

Event 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.

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

• Brand Name: DLP AORTIC ROOT ANTEGRADE ANTEGRADE CANNULA
• Type of Device: CATHETER, CANNULA AND TUBING, VASCULAR, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): PERFUSION SYSTEMS; 7611 northland dr; brooklyn park MN 55428
• Manufacturer (Section G): PERFUSION SYSTEMS; 7611 northland dr; brooklyn park MN 55428
• Manufacturer Contact: paula bixby ; 8200 coral sea street ne; mounds view, MN 55112 ; 7635055378
• MDR Report Key: 6586241
• MDR Text Key: 75814261
• Report Number: 2184009-2017-00020
• Device Sequence Number: 1
• Product Code: DWF
• UDI-Device Identifier: 20613994540113
• UDI-Public: 20613994540113
• Combination Product (y/n): N
• Reporter Country Code: SF
• PMA/PMN Number: K040173
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 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
• Device Operator: 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
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/24/2017
• Initial Date FDA Received: 05/23/2017
• Supplement Dates Manufacturer Received: Not provided; 05/23/2017
• Supplement Dates FDA Received: 06/20/2017; 09/07/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/20/2016
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Death