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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 Problem Pumping Stopped (1503)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 11/23/2018
Event Type  Injury  
Manufacturer Narrative
The bio-console instrument was returned and the reported flow issue was verified during service. Upon review of the event log, medtronic service found an error code 68 (loss of communication from base to the user interface) was logged just prior to the unit shutting down and turning back on. Based on the event log, medtronic service were unable to determine if the unit shut down and rebooted by itself or if the customer had initiated. Medtronic service was unable to duplicate the reported problem during testing at the service depot. The system controller module was replaced as a precautionary measure. Functional testing was performed per specifications with no issues noted. If information is provided in the future, a supplemental report will be issued.
 
Event Description
Medtronic received information that during use, the bio-console 560 instrument's pump stopped flowing. The patient was on pump at the time and was sustained using the hand crank. The flow stopped after 1hr41mins on bypass. The surgery was a cabg case. The distal anastomosis were complete and the aortic cross clamp had been removed. The perfusionist noticed the venous reservoir volume was increasing and used a tubing clamp to partially occlude the venous line. The perfusionist saw the 560 display panel flashing for approximately 5-8 seconds and then go black. The perfusionist was aware that there was no forward flow at the time as the patient's pressure was very low and the venous reservoir was filling up. She believed there to be no rpm at this time. The perfusionist did not look at the display on the base unit at this time. The instrument was successfully changed out with a backup and there was no resulting adverse patient effect.
 
Manufacturer Narrative
Additional information was received that the customer did cycle the power at one point during the incident. The root cause of this occurrence is undetermined. 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 Key8178277
MDR Text Key130772650
Report Number2184009-2018-00049
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,Followup
Report Date 03/07/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/19/2018
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 Manufacturer11/27/2018
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received02/11/2019
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured07/21/2006
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: 12/19/2018 Patient Sequence Number: 1
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