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

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.

• 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: 7326411
• MDR Text Key: 101954003
• Report Number: 2184009-2018-00007
• Device Sequence Number: 1
• Product Code: DWA
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K080824
• Number of Events Reported: 1
• 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

• 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: 12/25/2017
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/14/2018
• Initial Date FDA Received: 03/09/2018
• Supplement Dates Manufacturer Received: 07/18/2018
• Supplement Dates FDA Received: 08/15/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/21/2014
• 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