MAUDE Adverse Event Report: PERFUSION SYSTEMS BIOMEDICUS ONE PIECE FEMORAL CANNULA KIT; CATHETER, CANNULA AND TUBING, VASCULAR, CARDIO

Model Number	96600-021
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	Hemorrhage/Blood Loss/Bleeding (1888)
Date of Event	01/12/2022
Type of Reportable Event	Malfunction
Event or Problem Description
Medtronic received information that during use of a bio-medicus cannula, the customer reported that the cannula was damaged and that the cannula was leaking blood from the connection between the cannula and a connector.The cannula was inserted in the femoral vein.It was asked but unknown how much blood was lost due to the leak.No blood transfusion was required due to the leak.The device was replaced to complete the procedure.There was no patient impact associated with this event.Additional information received reported that the cannula was not heated or cooled prior to use, and there was no damage in the location of the sutures.
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.

• Brand Name: BIOMEDICUS ONE PIECE FEMORAL CANNULA KIT
• Common Device Name: CATHETER, CANNULA AND TUBING, VASCULAR, CARDIO
• 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: alison sweeney ; parkmore business park west; galway ; EI ; 091708096
• MDR Report Key: 13756174
• Report Number: 2184009-2022-00029
• Device Sequence Number: 4761538
• Product Code: DWF
• UDI-Device Identifier: 00613994490094
• UDI-Public: 00613994490094
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K884129
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 03/14/2022

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: 10/31/2023
• Device Model Number: 96600-021
• Device Catalogue Number: 96600-021
• Device Lot Number: 2019100629
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/14/2022
• Initial Report FDA Received Date: 03/14/2022
• Date Device Manufactured: 10/28/2019
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown