MAUDE Adverse Event Report: PERFUSION SYSTEMS DLP CARDIAC SUCTION TUBE; SUCKER, CARDIOTOMY RETURN, CARDIOPULMONARY BYP

Model Number	10050
Medical Device Problem Code	Obstruction of Flow (2423)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/27/2024
Type of Reportable Event	Malfunction
Additional 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 or Problem Description
Medtronic received information that during use of a dlp cardiac suction tube, it was reported that there was a blockage in the device and carbon dioxide was unable to flow through the device.The customer checked the gas line, filter and table tubing.The device was tested separately and found to be occluded.Another dlp cardiac suction tube was observed to have the same issue during use.The issue added additional time to procedure.The device was replaced to complete the procedure.There was no adverse patient effect associated with this event.Medtronic received additional information that there was no damage observed to either of the devices.
Additional Manufacturer Narrative
Device evaluation summary: visual inspection showed no outward signs of any damage.During the cleaning process there was little to no flow through the device.The device was cut apart and there was evidence of a blockage where the tubing was bonded to the handle.The reason for return was confirmed.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.
Additional 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.

• Brand Name: DLP CARDIAC SUCTION TUBE
• Common Device Name: SUCKER, CARDIOTOMY RETURN, CARDIOPULMONARY BYP
• 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: 20350000
• Report Number: 2184009-2024-00581
• Device Sequence Number: 15469441
• Product Code: DTS
• UDI-Device Identifier: 00613994698278
• UDI-Public: 00613994698278
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K791846
• 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,Followup,Followup
• Report Date (Section B): 03/03/2025

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: 07/13/2026
• Device Model Number: 10050
• Device Catalogue Number: 10050
• Device Lot Number: 2023070394
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/05/2024
• Supplement Date Received by Manufacturer: 10/03/2024; 02/22/2025
• Initial Report FDA Received Date: 10/02/2024
• Supplement Report FDA Received Date: 10/24/2024; 03/03/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/14/2023
• 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