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

Model Number A09075001

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/05/2016

Event Type  malfunction  

Manufacturer Narrative

The medtronic field service technician visited the facility to perform the repair.A review of the event log from the instrument confirmed the presence of error code 54.The field service technician replaced the rpm (revolutions per minute) potentiometer.After the repair the device was tested and performed within specifications.A review of the device history record confirmed that no anomalies were observed during manufacturing.A review of complaints identified no trends for the error code.

Event Description

Medtronic received information that as this bio console instrument was being prepared for use, the user interface displayed error code 54 (speed control).The instrument was replaced with a backup device before the case was initiated.There was no patient involvement in the event.A medtronic field service technician was dispatched to the facility to perform repair.

• Brand Name: BIO CONSOLE 560 USER INTERFACE
• 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: 6071114
• MDR Text Key: 58932086
• Report Number: 2184009-2016-00022
• 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: Other Health Care Professional
• Type of Report: Initial
• Report Date: 10/05/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/01/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: A09075001
• Device Catalogue Number: A09075001
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/10/2016
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/05/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/30/2005
• 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