MAUDE Adverse Event Report: PERFUSION SYSTEMS AFFINITY CP CENTRIFUGAL BLOOD PUMP; PUMP, BLOOD, CARDIOPULMONARY BYPASS, NON-ROLLE

Model Number	AP40
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/25/2025
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
It was reported that prior to use of the ap40 centrifugal pump, preparing for an emergency extracorporeal membrane oxygenation (ecmo) procedure in the interventional catheterization room.While connecting the centrifugal pump head to the circulation tubing, the centrifugal pump head broke.A new pump head was immediately used instead to continue the operation.No patient complications have been reported as a result of this event.
Event or Problem Description
It was reported that prior to use of the ap40 centrifugal pump, preparing for an emergency extracorporeal membrane oxygenation (ecmo) procedure in the interventional catheterization room.While connecting the centrifugal pump head to the circulation tubing, the centrifugal pump head broke.A new pump head was immediately used instead to continue the operation.No patient complications have been reported as a result of this event.Medtronic received photo of the defective pump head.
Additional Manufacturer Narrative
Additional review of the event and additional photo of the defective device received shows that there is no information to reasonably suggest that the device in this report may have caused or contributed to a death or serious injury or that the device in this report has malfunctioned.Therefore, this event did not and does not meet the reporting requirements in 21 cfr 803.¿ correction d3: updated the manufacturer name, and address 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: AFFINITY CP CENTRIFUGAL BLOOD PUMP
• Common Device Name: PUMP, BLOOD, CARDIOPULMONARY BYPASS, NON-ROLLE
• 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: 22802695
• Report Number: 9617601-2025-00966
• Device Sequence Number: 7836548
• Product Code: KFM
• UDI-Device Identifier: 00643169855205
• UDI-Public: (01)00643169855205(17)260517(10)228905188
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K201068
• 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): 11/04/2025

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: 05/17/2026
• Device Model Number: AP40
• Device Catalogue Number: AP40
• Device Lot Number: 228905188
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/13/2025
• Supplement Date Received by Manufacturer: 08/18/2025
• Initial Report FDA Received Date: 08/14/2025
• Supplement Report FDA Received Date: 11/04/2025
• Date Device Manufactured: 05/17/2024
• 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: Male