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

Model Number 560BCS1

Device Problems Excess Flow or Over-Infusion (1311); Self-Activation or Keying (1557); Device Displays Incorrect Message (2591)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/19/2014

Event Type  malfunction  

Event Description

Medtronic received information reporting that after priming, during the recirculation time prior to the patient procedure, the 560 bio-console displayed error codes (46, 47, 52) and the flow rate changed from 2 to 9 liters.The operator reportedly did not change the flow rate, and did not know what the displayed motor drive speed (revolutions per minute) was either before or after the flow change occurred.It seemed that the actual flow rate increased in correlation with the displayed flow rate, but the operator was not certain of this detail.The 560 bio-console was replaced with a 550 bio-console prior to starting the procedure and there was no resulting adverse patient effect.

Manufacturer Narrative

Initial inspection of the 560 bio-console in the medtronic technical service european operations center verified the reported motor drive error code and speed issue.To verify whether the performance anomaly was with the bio-console instrument itself or the external drive motor, testing was performed using the complaint instrument and a stock external drive motor.The reported problem was reproduced.Therefore the source of the problem was thought to be with the bio-console instrument.Review of the 560 bio-console event data log indicated that the motor speed (revolutions per minute) stopped functioning according to user control.The instrument will be returned to the u.S.Structural heart service depot for further analysis and investigation.(b)(4).

Manufacturer Narrative

The bio-console instument was returned from the medtronic technical service european operations center to the u.S.Structural heart service depot where the reported motor speed issue was verified.Inspection of the device found the motor speed to intermittently become erratic and then ramp up out of control.The cause for the motor issue was isolated to the motion/pressure module component of the instrument.(b)(4).

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

• Brand Name: BIO CONSOLE 560
• Type of Device: CONTROL, PUMP SPEED, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): PERFUSION SYSTEMS; 7611 northland dr; brooklyn park MN 55428
• Manufacturer (Section G): MEDTRONIC STRUCTURAL HEART; 8200 coral sea street ne; mounds view MN 55112
• Manufacturer Contact: paula bixby ; 8200 coral sea street ne; mounds view, MN 55112 ; 7635055378
• MDR Report Key: 4639216
• MDR Text Key: 5613862
• Report Number: 2184009-2015-00009
• Device Sequence Number: 1
• Product Code: DWA
• Combination Product (y/n): N
• Reporter Country Code: SP
• PMA/PMN Number: K070286
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility,Company Representative,company represent
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 07/09/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/27/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 560BCS1
• Device Catalogue Number: 560BCS1
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/14/2015
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/09/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/01/2014
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1