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

Model Number 20012

Device Problem Difficult to Remove (1528)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/04/2018

Event Type  malfunction  

Manufacturer Narrative

Product analysis visual inspection shows the male luer stem of needle introducer appears to have been inadvertently bonded to the female luer during assembly and when it was removed the luer stem cracked/broke.If information is provided in the future, a supplemental report will be issued.

Event Description

Medtronic received information that during use of a dlp aortic root cannula with vent line during cardioplegia, the needle in the cannula was more difficult to remove.The device was replaced.No adverse patient effects were reported.

• Brand Name: 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: 7831998
• MDR Text Key: 118883248
• Report Number: 2184009-2018-00027
• Device Sequence Number: 1
• Product Code: DWF
• UDI-Device Identifier: 20613994495505
• UDI-Public: 20613994495505
• Combination Product (y/n): N
• Reporter Country Code: TW
• PMA/PMN Number: K810548
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician Assistant
• Type of Report: Initial
• Report Date: 08/30/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/30/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/30/2020
• Device Model Number: 20012
• Device Catalogue Number: 20012
• Device Lot Number: 2017090539
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/21/2018
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/06/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/09/2017
• 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