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U.S. Department of Health and Human Services

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

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PERFUSION SYSTEMS BIO CONSOLE 560 USER INTERFACE CONTROL, PUMP SPEED, CARDIOPULMONARY BYPASS Back to Search Results
Model Number A09075001
Device Problem Device Operates Differently Than Expected (2913)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 10/05/2016
Event Type  malfunction  
Manufacturer Narrative
The medtronic field service technician visited the facility to perform the repair. A review of the event log from the instrument confirmed the presence of error code 54. The field service technician replaced the rpm (revolutions per minute) potentiometer. After the repair the device was tested and performed within specifications. A review of the device history record confirmed that no anomalies were observed during manufacturing. A review of complaints identified no trends for the error code.
 
Event Description
Medtronic received information that as this bio console instrument was being prepared for use, the user interface displayed error code 54 (speed control). The instrument was replaced with a backup device before the case was initiated. There was no patient involvement in the event. A medtronic field service technician was dispatched to the facility to perform repair.
 
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Brand NameBIO CONSOLE 560 USER INTERFACE
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 Key6071114
MDR Text Key58932086
Report Number2184009-2016-00022
Device Sequence Number1
Product Code DWA
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K080824
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
Report Date 10/05/2016
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received11/01/2016
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberA09075001
Device Catalogue NumberA09075001
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer10/10/2016
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received10/05/2016
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured11/30/2005
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse

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