MAUDE Adverse Event Report: PERFUSION SYSTEMS ADAPTER W/CHECK VALVE ON CONNECTOR ANTEGRADE PERFUSION; CATHETER, CANNULA AND TUBING, VASCULAR, CARDIO

Model Number 10534

Device Problem Obstruction of Flow (2423)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 03/21/2024

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 prior to use of a dlp ¿y¿ type venting adapter, it was reported that the one way valve in the device was not working.The device was replaced.There was no patient involvement, so no adverse effect occurred.Medtronic received additional information that typically, during bypass, the perfusionist flushes cardioplegia solution through the cardioplegia device and line to the table, then to the cardioplegia wye (returned), and finally back to the pump via the vent line.The vent includes a gravity loop, so when cardioplegia is flushed, there is minimal resistance unless the surgeon has accidentally clamped the wye somewhere.Despite flushing the cardioplegia, little to no solution passed the one-way valve in the cardioplegia wye.The team checked their clamps, finding only one on the cardioplegia cannula, as required to prevent solution or air from reaching the patient before applying the cross clamp.When high line pressures were detected back at the pump, the customer reported this.No obvious mechanical fault was found in the line, so the team opted to replace the wye.The second wye didn't present any issues, and no other components were changed.

• Brand Name: ADAPTER W/CHECK VALVE ON CONNECTOR ANTEGRADE PERFUSION
• 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: 19095362
• MDR Text Key: 340717576
• Report Number: 2184009-2024-00181
• Device Sequence Number: 1
• Product Code: DWF
• UDI-Device Identifier: 00613994685988
• UDI-Public: 00613994685988
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: K791498
• 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: 04/12/2024

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: 10534
• Device Catalogue Number: 10534
• Device Lot Number: 2023091088
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/21/2024
• Initial Date FDA Received: 04/12/2024
• Date Device Manufactured: 09/27/2023
• 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