MAUDE Adverse Event Report: PERFUSION SYSTEMS BIO CONSOLE 560 CONTROL, PUMP SPEED, CARDIOPULMONARY BYPASS

Model Number 560BCS1

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 04/20/2016

Event Type  Injury  

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

Event Description

Medtronic received information that during use, the bio-console instrument experienced back flow and no flow and alarms were heard when transferring to bypass. The revolutions per minute were increased but did not change the flow. The flow probe was checked, the line pressure was 225 mmhg, the line was clamped then the hand crank was used. The instrument was re-started and use of the instrument was continued to complete case with no adverse patient effect. The customer requested the instrument be evaluated so the field service technician was dispatched.

Manufacturer Narrative

Product analysis: the reported backflow was not verified by medtronic field service technician during on-site field analysis. The reported backflow alarms were confirmed by review of the event log. The event log data was used to plot revolutions per minute, flow, backflow alarms, and power cycles for the duration of the case as well as post-case instrument evaluation. Medtronic engineers reviewed the plot with the facility perfusionist. The event log data shows that the instrument was not re-started following the backflow alarms, but rather the motor was stopped and restarted. The perfusionist suspects a clamp may have been released with a purge line open causing temporary retro-verse flow when switching to bypass. This condition was quickly remedied by the user and positive flow was achieved for the duration of the case with no adverse patient effect. The field analysis and the evaluation of the event log indicate that the bio-console responded correctly throughout the case. Conclusion: the patient demographics were requested but were not provided by the health care facility. There was no instrument performance issues noted during post-case instrument evaluation.

Event Description

Medtronic received information that during use the bioconsole instrument experienced back flow and no flow and alarms were heard when transferring to bypass. The revolutions per minute were increased but did not change the flow. The flow probe was checked, the line pressure was 225 mmhg, the line was clamped then the hand crank was used. The instrument was re-started and use of the instrument was continued to complete case with no adverse patient effect. The customer requested the instrument be evaluated so the field service technician was dispatched.

• Brand Name: BIO CONSOLE 560
• Type of Device: 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: paula bixby ; 8200 coral sea street ne; mounds view, MN 55112 ; 7635055378
• MDR Report Key: 5651315
• MDR Text Key: 101854410
• Report Number: 2184009-2016-00011
• Device Sequence Number: 1
• Product Code: DWA
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K070286
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 12/01/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/12/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes

Device Operator

• Device Model Number: 560BCS1
• Device Catalogue Number: 560BCS1
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/21/2016
• Is the Reporter a Health Professional?: Yes

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 11/16/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/08/2014
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse

Patient Treatment Data

Date Received: 05/12/2016 Patient Sequence Number: 1