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

Model Number	560A
Medical Device Problem Code	Obstruction of Flow (2423)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/14/2024
Type of Reportable Event	Malfunction
Event or Problem Description
Medtronic received information that during use of an external drive motor instrument, it was reported that cardiopulmonary bypass was initiated with flows at 2.1 index.Over the next 10 minutes flows gradually dropped for no apparent reason.Surgeon was notified.He ordered bypass terminated pump head was re-seated, lines checked, cannulas checked.Bypass reinitiated but flows still would not come up.The instrument was replaced to complete the procedure.There was no adverse patient effect associated with this event.
Additional Manufacturer Narrative
Device evaluation summary: the reported low flow issue was not verified during service.Service technician could not confirm an issue with the unit, as it performed as designed.Verified proper operation.Performed complete performance verification and calibration procedures according to manufacturer specifications.Instrument passed all tests.Preventive maintenance was performed as per specification.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 received additional information that, due to the reported issue, the flow to the patient was decreased.In order to address the issue, the customer increased the rpm, re-seated the pump head and checked for kinks on the instrument.A hand-crank was not used and there was no error messages displayed.The following safety systems were in use during the procedure: level sensor, bubble detectors, alarms and arterial line pressure sensors.Device evaluation summary: the reported flow issue was not verified during service.The service technician could not confirm any issue with the instrument and it was performing as designed.Preventive maintenance was performed per specifications.Note: the instrument was serviced in the field by a medtronic field service technician.The instrument was not returned to a medtronic facility.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: 20461490
• Report Number: 2184009-2024-00630
• Device Sequence Number: 8701796
• Product Code: DWA
• UDI-Device Identifier: 00763000108281
• UDI-Public: 00763000108281
• Combination Product (Y/N): N
• Initial Reporter State: WV
• 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
• Report Date (Section B): 11/07/2024

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
• Operator of Device: Health Professional
• Device Model Number: 560A
• Device Catalogue Number: 560A
• 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: 10/14/2024
• Supplement Date Received by Manufacturer: 10/15/2024
• Initial Report FDA Received Date: 10/16/2024
• Supplement Report FDA Received Date: 11/07/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/11/2020
• Is the Device Labeled for Single Use? (Y/N): No
• 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 Age: 63 YR
• Patient Sex: Male
• Patient Weight: 105 KG