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	03/29/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device evaluation summary: the reported rpms would not increase past 0 issue, was verified during service.Service technician observed during inspection/ evaluation, that after attaching the motor to a known good 560 base with ui.And after boot-up, service technician attempted to increased rpm knob just past zero detent, and found rpm ramping up to the max.Service technician immediately turned rpm knob to zero and disconnected motor.Service technician observed that motor will not start unless it is rotated slightly and then ramps up to max when started, also found a cut in the cable which has severed wires which caused the reported problem.Issue was resolved by replacing the external drive motor shield and the cover magnet.Preventive maintenance was performed as per specification.Conclusion: complaint confirmed for the reported rpms not increasing past 0 issue during service.Ecmo use per supplemental ifu extended use was deemed to not produce undue risk and this occurrence was not a result of the extended use of the device.There were no patient/clinical safety issues reported.The service history record was not reviewed as returned product analysis found no evidence of servicing issues with the serviced device.Trends for issues with this product are reviewed at quarterly quality meetings.This regulatory report is being submitted as part of a retrospective review and remediation per d00953163 as part of a capa action.Medtronic is submitting this report to comply with fda reporting regulations under 21 cfr parts 4 and 803.This report is based upon information obtained by medtronic, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Medtronic has made reasonable efforts to obtain more complete information and has provided 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.In particular, this report does not constitute an admission by anyone that the product described in this report has any ¿defects¿ or has ¿malfunctioned¿.These words are included in the fda 3500a form and are fixed items for selection created by the fda to categorize the type of event solely for the purpose of regulatory reporting.Medtronic objects to the use of these words and others like them because of the lack of definition and the connotations implied by these terms.This statement should be included with any information or report disclosed to the public under the freedom of information act.A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
Medtronic received information that during use of this external drive motor instrument the cone decoupled, the cone was changed out in 30 seconds, when the cone was seated however, the rpms would not increase with the knob being turned.The knob was turned back off past click, and turned again and the rpms would not increase past 0.This was repeated four times before changing the motor.The motor was taken off the backup circuit and plugged in, the rpms were increased successfully, and the patient was back on extra corporeal membrane oxygenation (ecmo) after 90 seconds.There was no adverse patient effect associated with this event.Additional information received indicates that the hand crank was not required at any stage during the swap out to maintain flow.The clinical procedure is confirmed as being ecmo, no further information is available.It is unknown how long the patient was on e cmo prior to pump head and motor failure.The cone/pump head decoupling and the failure of motor a1620 is all that can be verified for this complaint.

• 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: 17048808
• Report Number: 2184009-2023-00397
• Device Sequence Number: 14325545
• 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
• Report Date (Section B): 06/02/2023

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
• Date Returned to Manufacturer: 08/23/2021
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/29/2021
• Initial Report FDA Received Date: 06/02/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/03/2018
• 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 Sex: Unknown