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

Model Number 560BC

Device Problems Failure to Run on Battery (1466); Pumping Stopped (1503)

Patient Problem No Consequences Or Impact To Patient (2199)

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 this bio-console instrument with percutaneous cardiopulmonary support (pcps), the instrument was unable to be used in battery power mode.The instrument could not be used without ac power supply.The procedure was completed with use of the hand crank and by replacing the instrument with a backup.There was no reported adverse patient effect.

Manufacturer Narrative

The reported battery power mode issue was verified during service.Medtronic service confirmed output instability of the power supply circuit.The issue was resolved by replacing the power supply circuit board and the system controller board.Functional testing was completed per specifications.If information is provided in the future, a supplemental report will be issued.

Manufacturer Narrative

Product analysis is ongoing.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
• MDR Report Key: 8527226
• MDR Text Key: 142353162
• Report Number: 2184009-2019-00015
• Device Sequence Number: 1
• Product Code: DWA
• Combination Product (y/n): N
• PMA/PMN Number: K080824
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup,Followup
• Report Date: 06/07/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/18/2019
• 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: 04/11/2019
• Date Manufacturer Received: 05/27/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention