MAUDE Adverse Event Report: PERFUSION SYSTEMS DLP SINGLE STAGE VENOUS CANNULA; CATHETER, CANNULA AND TUBING, VASCULAR, CARDIOPULMONARY BYPASS

Model Number	66116
Medical Device Problem Code	Split (2537)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); No Patient Involvement (2645)
Date of Event	05/03/2018
Type of Reportable Event	Malfunction
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 use of the single stage venous cannula, while fixing the cannula with a silk thread the cannula broke-up (split) not allowing a sealed environment.The product was replaced.There was no adverse effect on the patient.The procedure took longer due the cannula been replaced.
Additional Manufacturer Narrative
Additional information: the initial reporter information has been updated.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 SINGLE STAGE VENOUS 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: 7604563
• Report Number: 2184009-2018-00014
• Device Sequence Number: 1590131
• Product Code: DWF
• UDI-Device Identifier: 20613994878513
• UDI-Public: 20613994878513
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K033264
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 10/04/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 08/31/2020
• Device Model Number: 66116
• Device Catalogue Number: 66116
• Device Lot Number: 2017080960
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 05/17/2018
• Supplement Date Received by Manufacturer: 07/05/2018; 08/08/2018
• Initial Report FDA Received Date: 06/15/2018
• Supplement Report FDA Received Date: 07/19/2018; 10/04/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 1 YR
• Patient Weight: 3