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

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.

• Brand Name: 560BC BIO CONSOLE
• Type of Device: CONTROL, 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 Key: 8178277
• MDR Text Key: 130772650
• Report Number: 2184009-2018-00049
• Device Sequence Number: 1
• Product Code: DWA
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K080824
• Number of Events Reported: 1
• 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

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 560BC
• Device Catalogue Number: 560BC
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/27/2018
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/23/2018
• Initial Date FDA Received: 12/19/2018
• Supplement Dates Manufacturer Received: 02/11/2019
• Supplement Dates FDA Received: 03/07/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/21/2006
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 47 YR
• Patient Weight: 95