MAUDE Adverse Event Report: PERFUSION SYSTEMS BIO-MEDICUS CANNULA; CATHETER, CANNULA AND TUBING, VASCULAR, CARDIO

Model Number 96570-015

Device Problem Fluid/Blood Leak (1250)

Patient Problem Hemorrhage/Bleeding (1888)

Event Date 01/12/2022

Event Type  malfunction  

Event Description

Medtronic received information that during use of a bio-medicus cannula, the customer reported that the cannula was leaking blood from the connection between the cannula and a connector.The cannula was inserted in the femoral artery.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.

Manufacturer Narrative

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

• Brand Name: BIO-MEDICUS CANNULA
• Type of Device: 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: 13771575
• MDR Text Key: 289269841
• Report Number: 2184009-2022-00031
• Device Sequence Number: 1
• Product Code: DWF
• UDI-Device Identifier: 00643169880764
• UDI-Public: 00643169880764
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K924642
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 03/15/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/15/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 96570-015
• Device Catalogue Number: 96570-015
• Device Lot Number: 2021050224
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/14/2022
• Date Device Manufactured: 05/05/2021
• 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