MAUDE Adverse Event Report: PERFUSION SYSTEMS MOTOR EXTERNAL DRIVE; CONTROL, PUMP SPEED, CARDIOPULMONARY BYPASS

Model Number	560A
Medical Device Problem Codes	Device Alarm System (1012); Mechanical Problem (1384)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/29/2024
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 prior to use of a external drive motor instrument, it was reported that the motor head had a malfunction.The instrument was replaced.There was no patient involvement, so no adverse effect occurred.
Additional Manufacturer Narrative
Correction b5: medtronic received information that prior to use of an external drive motor instrument, it was reported that the motor head had a malfunction.The display showed a "motor head malfunction" alert.The instrument was replaced.There was no patient involvement, so no adverse effect occurred.Correction h6: updated the fdd/ annex a codes and the rfr code 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
Device evaluation summary: the reported motor head had a malfunction.The display showed a "motor head malfunction" alert was not verified during service.The service technician ran the instrument for 4hrs with no errors.The motor was a little loud at full rpm's.The depth of the magnet was reading.094 on all four spots.The service technician replaced the cover m938278a001 magnet and set the magnet to.096 on all 4 spots and ran for 3 days for 8hrs each day with no errors, the motor was humming normal at different settings on the rpm.S.Preventive maintenance was performed per specifications.Additional info h6: updated the annex b and the annex c codes 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: MOTOR EXTERNAL DRIVE
• Common Device Name: CONTROL, PUMP SPEED, CARDIOPULMONARY BYPASS
• 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: 20620437
• Report Number: 2184009-2024-00685
• Device Sequence Number: 12988012
• Product Code: DWA
• UDI-Device Identifier: 00613994647832
• UDI-Public: 00613994647832
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K191077
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 04/01/2025

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 Model Number: 560A
• Device Catalogue Number: 560A
• 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: 10/30/2024
• Supplement Date Received by Manufacturer: 12/06/2024; 03/18/2025
• Initial Report FDA Received Date: 11/06/2024
• Supplement Report FDA Received Date: 12/09/2024; 04/01/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/07/2011
• 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: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown