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U.S. Department of Health and Human Services

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

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PERFUSION SYSTEMS BIO CONSOLE 560 CONTROL, PUMP SPEED, CARDIOPULMONARY BYPASS Back to Search Results
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.
 
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Brand NameBIO CONSOLE 560
Type of DeviceCONTROL, 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 Key5651315
MDR Text Key101854410
Report Number2184009-2016-00011
Device Sequence Number1
Product Code DWA
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K070286
Number of Events Reported1
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 Received05/12/2016
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model Number560BCS1
Device Catalogue Number560BCS1
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer04/21/2016
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received11/16/2016
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured04/08/2014
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
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