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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 Insufficient Flow or Under Infusion (2182)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 02/20/2021
Event Type  Injury  
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Event Description
Medtronic received information that during use of this bio-console instrument during an extra corporeal membrane oxygenation (ecmo) case using the instrument and motor after 90 minutes of use, the patient was assembled and ecmo support was started with the new equipment, and a low flow alarm presented at the half hour. The customer stated that there was no presence of cavitation, or obstruction in the flow and the flowmeter was properly placed. The customer did not observe changes in the rpm, so they changed to the manual motor (hand crank), and then the external motor was changed and the support was reset with the patient at 65%, during the event. No hemodynamic changes were observed. Use of instrument was unspecified and there was no adverse patient effect associated with this event. Additional information was received on 15 april 2021 stating that the hand crank was used for less than 30 minutes.
 
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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
toni o'doherty
parkmore business park west
galway 
EI  
091708734
MDR Report Key11824201
MDR Text Key250610539
Report Number2184009-2021-00038
Device Sequence Number1
Product Code DWA
Combination Product (y/n)N
Reporter Country CodeCO
PMA/PMN Number
K080824
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation Physician Assistant
Type of Report Initial,Followup,Followup
Report Date 10/05/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/14/2021
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? Yes
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received09/06/2021
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured05/02/2012
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: 05/14/2021 Patient Sequence Number: 1
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