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	06/10/2024
Type of Reportable Event	Malfunction
Event or Problem Description
Medtronic received information that during use of a dlp cardiac suction tube, it was reported that the fine suction was not working, and customer was unable to aspirate any blockages.Another fine suction was handed in with the same lot number and the same issue occurred.The device was replaced with one from a different lot number to complete the procedure.There was no adverse patient effect associated with this event.Medtronic received additional information that the customer does not know if the tubing was bent or occluded.The metal tubing is malleable and designed to be bent to the surgeon's preference.Since there was no suction, the lumen appeared to be occluded somewhere inside the metal or plastic tubing.The replacement from a different lot worked fine, so likely this was not user error.
Additional Manufacturer Narrative
Device evaluation summary: visual inspection shows no outward signs of any damage.During the cleaning process there was no flow observed through the device.The device was cut apart and there is evidence of a blockage in the end of the tubing inside the handle.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
Correction b5: medtronic received information that during use of a dlp cardiac suction tube, it was reported that the fine suction was not working, and customer was unable to aspirate any blockages.Another fine suction was handed in with the same lot number and the same issue occurred.The devices were replaced with one from a different lot number to complete the procedure.There was no adverse patient effect associated with this event.Medtronic received additional information that the customer does not know if the tubing was bent.The metal tubing is malleable and designed to be bent to the surgeon's preference.Since there was no suction, the lumen appeared to be occluded somewhere inside the metal or plastic tubing.The replacement from a different lot worked fine, so likely this was not user error.Correction d2 product code: updated.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: 19929641
• Report Number: 2184009-2024-00467
• Device Sequence Number: 19523086
• 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
• Report Date (Section B): 02/27/2025

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
• Date Returned to Manufacturer: 07/12/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/10/2024
• Supplement Date Received by Manufacturer: 02/22/2025
• Initial Report FDA Received Date: 08/07/2024
• Supplement Report FDA Received Date: 02/27/2025
• 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