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

Model Number 560BCS1

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 04/17/2017

Event Type  Injury  

Manufacturer Narrative

The reported depleted battery was verified in the field by medtronic service technician.The service technician ran the instrument until the batteries were charged.Further analysis found that the batteries were over five years old.The issue was resolved by replacing the batteries.Final testing was performed per specification.The device history record was reviewed to show that the instrument passed all in-process inspections and tests.No abnormalities were noted during the manufacture of this instrument.Batteries are to be replaced every four years per the preventive maintenance schedule.A review of complaint and service records for june 2012 to april 2017 associated with this instrument found no other instances of battery replacement.A review of complaints identified no current trends.

Event Description

Medtronic received information that during use of this 560 bio console instrument the instrument powered off and a hand crank was used until the instrument could be plugged into power source.The hand crank was again used during patient transport as there was not sufficient time allowed to recharge the batteries.There were no adverse patient effects associated with this event.

Manufacturer Narrative

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

Manufacturer Narrative

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

Event Description

Medtronic received information that after approximately 25 minutes of using this 560 bio-console instrument on battery power, the instrument displayed the battery charge symbol on the user interface.The instrument had been running at approximately 2000-2500 revolutions per minute (rpms) and powered off after approximately 30 minutes.The hand crank was used until the instrument could be plugged into a power source in the ambulance.The hand crank was again used during patient transport into the hospital as there was not sufficient time allowed to recharge the batteries.There were no adverse patient effects associated with this event.

• 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: 6564651
• MDR Text Key: 75105074
• Report Number: 2184009-2017-00018
• Device Sequence Number: 1
• Product Code: DWA
• UDI-Device Identifier: 00613994450463
• UDI-Public: 00613994450463
• 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: company representative,health
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 11/28/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/29/2013
• Device Model Number: 560BCS1
• Device Catalogue Number: 560BCS1
• Was Device Available for Evaluation?: No
• Date Returned to Manufacturer: 04/19/2017
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 04/19/2017
• Initial Date FDA Received: 05/12/2017
• Supplement Dates Manufacturer Received: 04/19/2017; 04/19/2017
• Supplement Dates FDA Received: 10/03/2017; 11/28/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/29/2012
• 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
• Patient Outcome(s): Required Intervention