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U.S. Department of Health and Human Services

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

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PERFUSION SYSTEMS 560BC BIO CONSOLE CONTROL, PUMP SPEED, CARDIOPULMONARY BYPASS Back to Search Results
Model Number 560BC
Device Problems Device Operates Differently Than Expected (2913); Pumping Problem (3016)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 12/22/2017
Event Type  Injury  
Manufacturer Narrative
Product has not been returned for analysis. If information is provided in the future, a supplemental report will be issued.
 
Event Description
Medtronic received information that during use of the bio-console 560 there was a burning smell from the console. The instrument was replaced with a backup. Impact to patient was asked but unknown. Additional information was received that the cardiopulmonary bypass was temporarily performed by manual means using the hand crank while the bio-console was replaced.
 
Manufacturer Narrative
The bio-console instrument was returned and the reported burning smell was verified during service. Medtronic service noted that the diode on the motor-control board was burned and damaged. The issue was resolved by replacing the motor-control board. During service the sc board was also replaced due to an error with resolve. The impedance of the rpm pot was stabilised. A nut for the fan was detached, the issue was resolved by repairing the nut. The internal battery and fan filer were replaced as part of preventive maintenance. Functional testing was performed per specifications. Trends for issues with this product are monitored. If information is provided in the future, a supplemental report will be issued.
 
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Brand Name560BC BIO CONSOLE
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 Key7326411
MDR Text Key101954003
Report Number2184009-2018-00007
Device Sequence Number1
Product Code DWA
Combination Product (y/n)N
Reporter Country CodeJA
PMA/PMN Number
K080824
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation Medical Technologist
Type of Report Initial,Followup
Report Date 08/15/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/09/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model Number560BC
Device Catalogue Number560BC
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer12/25/2017
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received07/18/2018
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured02/21/2014
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

Patient Treatment Data
Date Received: 03/09/2018 Patient Sequence Number: 1
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