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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 Increased Pump Speed (1501)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 01/02/2020
Event Type  Injury  
Manufacturer Narrative
The bio-console instrument was analysed by a medtronic field service technician and the reported ramp up to 6,000 rpm was verified during service. The issue was resolved by replacing the assy, 560 m/p module. Preventive maintenance was performed per specifications. Trends for this product are monitored. Device evaluation was carried out in the facility by a medtronic service technician. The date service was carried out has been used as the return date. If information is provided in the future, a supplemental report will be issued.
 
Event Description
Medtronic received information that during use this bio-console instrument ramped up to 6,000 rpm. The external motor drive was replaced and the issue occurred again. The instrument was changed out with a backup and there was no resulting adverse patient effect. It was reported that the customer used the hand crank when switching over between motors and bio-consoles.
 
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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 Key9705870
MDR Text Key179254859
Report Number2184009-2020-00009
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 Physician Assistant
Type of Report Initial
Report Date 02/13/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/13/2020
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 Manufacturer01/15/2020
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received01/15/2020
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured01/23/2018
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unkown

Patient Treatment Data
Date Received: 02/13/2020 Patient Sequence Number: 1
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