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 01/15/2017

Event Type  Injury  

Manufacturer Narrative

The product has not been received in medtronic service for analysis.Upon completion of the analysis and investigation, a supplemental report will be filed.

Event Description

Medtronic received information that during use of this bio console 560 instrument, the display screen went blank and the master power switch was shut off and back on to recover the display functionality.During the restart of the instrument, the flow revolution per minute (rpm) stopped and a hand crank was used to maintain flow.The instrument was changed out with a backup and there was no adverse patient effect.The instrument will be returned to medtronic service.

Manufacturer Narrative

Upon receipt at medtronic¿s service depot, analysis of the bio-console base unit determined that the instrument was functioning as expected.The display screen performance issues were not verified during analysis.A review of the device history record for this device confirmed that no anomalies were observed during manufacturing.A review of prior complaints and service records for this device found no previously reported issues with the system controller board or the power supply.A review of complaints identified no current trends.

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 during use of this bio-console 560 instrument, the display screen went blank and the master power switch was shut off and back on to recover the display functionality.During the restart of the instrument the flow revolution per minute (rpm) stopped and a hand crank was used to maintain flow.The instrument was changed out with a backup and there was no adverse patient effect.

• 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: 6304554
• MDR Text Key: 66664524
• Report Number: 2184009-2017-00008
• Device Sequence Number: 1
• Product Code: DWA
• Combination Product (y/n): N
• Reporter Country Code: NZ
• PMA/PMN Number: K070286
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 12/01/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/06/2017
• 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: 03/06/2017
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/16/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/18/2006
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention