MAUDE Adverse Event Report: PERFUSION SYSTEMS 540T EXTERNAL DRIVE MOTOR; CONTROL, PUMP SPEED, CARDIOPULMONARY BYPASS

Model Number FA95120-003

Device Problem Increased Pump Speed (1501)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/05/2016

Event Type  Injury  

Manufacturer Narrative

At this time the product has not been returned for analysis and no definitive conclusions can be made regarding the root cause of the clinical observation.Medtronic's investigation is in process.A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.

Event Description

Medtronic received information reporting that during use of this 540t external driver motor, used on a 550 bio-console instrument, the unit experienced an increase in flow after four hours of regular performance.The user noticed a flow increase (1 l/min, cerebral pressure: 77mmhg to 5 l/min, cerebral pressure: 220 mmhg) and the motor had a high acoustic noise.The user stopped the pump with the rpm (revolutions per minute) potentiometer controller and powered off the 550 bio-console.When the instrument was powered back on the rpm displayed was 500 rpm, but the effective speed was high and the flow/cerebral pressure were also high.A hand crank was used for thirty seconds while the external driver motor was changed with a backup (serial number (b)()).The perfusion case was successfully completed.The patient expired post-surgery due to bleeding.It was confirmed that patient's death was unrelated to the external drive motor.It was stated that the external driver motor will be returned for analysis, but has not yet been received.

Manufacturer Narrative

Complaint was confirmed for the reported flow increase.The 540t external drive motor was out of specification and would not spin.The issue was resolved by replacing the motor, lower housing unit, and magnet window.The device was cleaned and the magnet calibrated.It is unknown what may have caused this occurrence.Post-repair testing was performed per specifications.Review of the device history record found no abnormalities during manufacturing that would cause or contribute to the reported event.The patient expired post-surgery due to bleeding.It was confirmed that patient¿s death was unrelated to the external drive motor.There are no current trends.

Event Description

Medtronic received information reporting that during use of this 540t external drive motor, used on a 550 bio-console instrument, the unit experienced an increase in flow after four hours of regular performance.The user noticed a flow increase (1 l/min, cerebral pressure: 77mmhg to 5 l/min, cerebral pressure: 220 mmhg) and the motor had a high acoustic noise.The user stopped the pump with the rpm (revolutions per minute) potentiometer controller and powered off the 550 bio-console.When the instrument was powered back on the rpm displayed was 500 rpm, but the effective speed was high and the flow/cerebral pressure were also high.A hand crank was used for thirty seconds while the external driver motor was changed with a backup (serial number (b)(4)).The perfusion case was successfully completed.The patient expired post-surgery due to bleeding.It was confirmed that patient¿s death was unrelated to the external drive motor.The product was returned for analysis.

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.

• Brand Name: 540T EXTERNAL DRIVE MOTOR
• 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: 6052201
• MDR Text Key: 58243201
• Report Number: 2184009-2016-00019
• Device Sequence Number: 1
• Product Code: DWA
• Combination Product (y/n): N
• Reporter Country Code: IT
• PMA/PMN Number: K051303
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• 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: 10/24/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: FA95120-003
• Device Catalogue Number: FA95120-003
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/21/2016
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/16/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/01/2002
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 68 YR
• Patient Weight: 85