MAUDE Adverse Event Report: PERFUSION SYSTEMS EOPA ARTERIAL CANNULA; CATHETER, CANNULA AND TUBING, VASCULAR, CARDIO

Model Number 77424

Device Problems Fluid/Blood Leak (1250); Mechanical Problem (1384)

Patient Problem Hemorrhage/Bleeding (1888)

Event Date 03/25/2024

Event Type  malfunction  

Manufacturer Narrative

Medtronic submits this report to comply with fda regulations 21 cfr parts 4 and 803.Medtronic has made reasonable efforts to provide as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.Medtronic will submit a supplemental report if additional relevant information becomes known.

Event Description

Medtronic received information that during use of an eopa arterial cannula, it was reported that there was a small amount of patient blood loss from the device during cannulation.There was approximately 100-200mls of blood loss.The customer stated that the white stylus appeared too small/narrow for the cannula which resulted in a messy cannulation. the customer stated that they are an experienced cannulator.There was no transfusion required.The cannula was not heated or cooled prior to cannulation.The patient was already heparinised, therefore, the blood was returned to the extracorporeal bypass circuit and then to the patient circulation once the bypass circuit was connected to the aortic cannula.The device was used.There was no adverse patient effect associated with this event.

• Brand Name: EOPA ARTERIAL 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: 19123139
• MDR Text Key: 341260779
• Report Number: 2184009-2024-00188
• Device Sequence Number: 1
• Product Code: DWF
• UDI-Device Identifier: 00763000135645
• UDI-Public: 00763000135645
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K031037
• 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: 04/17/2024

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
• Device Operator: Health Professional
• Device Model Number: 77424
• Device Catalogue Number: 77424
• Device Lot Number: 2023070728
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/25/2024
• Initial Date FDA Received: 04/17/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 07/19/2023
• 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