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

Model Number	560A
Medical Device Problem Code	Pumping Stopped (1503)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	05/02/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The bio-console external drive motor was evaluated.The motor failure was not verified during service.Service was unable to duplicate the reported issue.Performance check was performed per specifications with no issues noted.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
Medtronic received information that during use this bio-console external drive motor instrument failed to start when perfusionist turned rpm knob.The instrument was replaced with a back up and there was no reported adverse patient effect.The bio-console instrument had been set up and recirculated earlier in the day and kept running for about 4 hours while they waited to initiate bypass with no issues noted.Customer noted patient pressure dropped to zero, they had rpms but no forward flow.Customer attempted to troubleshoot the issue and then began to handcrank to produce forward flow at about 2000 rpms.Customer changed out external drive motor by swapping out the cables and initiated cpb again after five minutes.
Additional Manufacturer Narrative
The motor failure was confirmed based on assessment of the instrument's error log.The error log showed the customer rebooted and duplicated the issue with a motor error and a hard error.This confirmed what the customer experienced; rpm¿s, but no forward flow.The issue could not be replicated during service.Cause could not be established for why the flow rate was zero when the motor rpm's were running.Trends for issue with this product are monitored.If information is provided in the future, a supplemental report will be issued.

• 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
• MDR Report Key: 8616180
• Report Number: 2184009-2019-00021
• Device Sequence Number: 16771974
• Product Code: DWA
• UDI-Device Identifier: 00613994647832
• UDI-Public: 00613994647832
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K100631
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician Assistant
• Type of Report: Initial,Followup
• Report Date (Section B): 06/12/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• 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: 05/06/2019
• Initial Date Received by Manufacturer: 05/02/2019
• Supplement Date Received by Manufacturer: 05/17/2019
• Initial Report FDA Received Date: 05/16/2019
• Supplement Report FDA Received Date: 06/12/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention