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

Model Number E560BC73

Device Problem Pumping Stopped (1503)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 02/12/2015

Event Type  Injury  

Event Description

Medtronic received information that during a case this 560 bio-console instrument switched into coast mode.A perfusionist who was unfamiliar with the instrument had the bubble detector activated and set to switch the motor off if a bubble was detected.During bypass, the perfusionist manipulated the tubing and separated the bubble detector from the line.The pump switched into coast mode.Since the bubble detector had not been adjusted and the instrument continued to detect a bubble, the unit remained in coast mode.The perfusionist could not deactivate the mode, and needed to use the hand crank to maintain flows until a replacement bio-console could be brought in for use.There were no adverse patient effects.

Manufacturer Narrative

Performance testing of the bio-console was performed by the bio-med at the hospital, and it was reported that the instrument operated as intended with no evidence of a malfunction.The medtronic sales representative has scheduled a training session with the perfusionist on the operation of the bio-console and its safety systems.(b)(4).

• 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: 4592867
• MDR Text Key: 5482158
• Report Number: 2184009-2015-00004
• Device Sequence Number: 1
• Product Code: DWA
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K070286
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date: 02/12/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/11/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: E560BC73
• Device Catalogue Number: E560BC73
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/12/2015
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention