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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 11/07/2016
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 within five minutes of bypass when the operator was ramping up between 2-3 liters/minute, the user interface on this bio-console instrument went blank and the pump motor stopped. The hand crank was used to maintain forward flow until the bio-console was rebooted and the user interface and the motor drive resumed function. The user interface, bio-console and external motor were changed out with backups and there was no resulting adverse patient effect.
 
Manufacturer Narrative
The medtronic field service technician visited the facility to perform the repair. The field analysis found that an a/d converter error had occurred. The field service technician replaced the system controller board and the power supply. After the repair the device was tested and performed within specifications. A review of the device history record for this device confirmed that no anomalies were observed during manufacturing. A review of prior complaints and service records for this device found no previously reported issues with the system controller board or the power supply. A review of complaints identified no current trends.
 
Event Description
Medtronic received information that during use within five minutes of bypass when the operator was ramping up between 2-3 liters/minute, the user interface on this bioconsole instrument went blank and the pump motor stopped. The hand crank was used to maintain forward flow until the bioconsole was rebooted and the user interface and the motor drive resumed function. The user interface, bioconsole and external motor were changed out with backups and there was no resulting adverse patient effect. Field service technician was dispatched to the facility to service the bioconsole.
 
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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 Key6145570
MDR Text Key101855108
Report Number2184009-2016-00032
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
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 Received12/05/2016
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 Manufacturer11/11/2016
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received11/16/2017
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured06/01/2012
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

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