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

Model Number 560BCS1

Device Problem Increased Pump Speed (1501)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/02/2020

Event Type  Injury  

Manufacturer Narrative

The bio-console instrument was analysed by a medtronic field service technician and the reported ramp up to 6,000 rpm was verified during service.The issue was resolved by replacing the assy, 560 m/p module.Preventive maintenance was performed per specifications.Trends for this product are monitored.Device evaluation was carried out in the facility by a medtronic service technician.The date service was carried out has been used as the return date.If information is provided in the future, a supplemental report will be issued.

Event Description

Medtronic received information that during use this bio-console instrument ramped up to 6,000 rpm.The external motor drive was replaced and the issue occurred again.The instrument was changed out with a backup and there was no resulting adverse patient effect.It was reported that the customer used the hand crank when switching over between motors and bio-consoles.

• 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): 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: 9705870
• MDR Text Key: 179254859
• Report Number: 2184009-2020-00009
• Device Sequence Number: 1
• Product Code: DWA
• UDI-Device Identifier: 00643169315822
• UDI-Public: 00643169315822
• 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: Physician Assistant
• Type of Report: Initial
• Report Date: 02/13/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/13/2020
• Is this an Adverse Event Report?: Yes
• 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: 01/15/2020
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/15/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/23/2018
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention