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

Model Number	77108
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Hypovolemia (2243)
Date of Event	01/30/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Medtronic is unable to determine the root cause of the issue at the current time without the return of the product.Medtronic is continuing to pursue additional information and has made requests for the return of the device if it is removed from the patient.From other; device has been requested but has not been returned yet.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
Medtronic received information that during use of a dlp paediatric one-piece arterial cannula approximately 27 minutes after first use of the cannula the anaesthetist noticed the presence of blood coming from a split in the cannula.A cupula was implemented under the canula to recover lost blood.It is unknown if the cannula was replaced.The patient experience hypovolemia.
Additional Manufacturer Narrative
Visual analysis: visual inspection shows evidence of a crack in the fitting/connector at the interface between the body and the connector.Performance analysis: during the cleaning process there was a leak observed from the connector/cannula body interface.If information is provided in the future, a supplemental report will be issued.

• Brand Name: ARTERIAL 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: 7316323
• Report Number: 2184009-2018-00006
• Device Sequence Number: 1605756
• Product Code: DWF
• UDI-Device Identifier: 20613994879947
• UDI-Public: 20613994879947
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K024069
• 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
• Report Date (Section B): 11/09/2018

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: 77108
• Device Catalogue Number: 77108
• Device Lot Number: 2017080688
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/09/2018
• Initial Date Received by Manufacturer: 02/06/2018
• Supplement Date Received by Manufacturer: 10/15/2018
• Initial Report FDA Received Date: 03/06/2018
• Supplement Report FDA Received Date: 11/09/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1