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 Code Available (3191)

Event Date 06/11/2014

Event Type  Injury  

Event Description

Medtronic received information that on the third attempt to terminate bypass surgery, the 560 bio-console was brought down first to a half and then to a quarter flow.At that time, the cardiotomy reservoir level sensor alarm tripped, which automatically activated the arterial line (auto) clamp.In order to reopen the autoclamp, the perfusionist turned the rpms to zero and then back up to greater than 2000 revolutions per minute (rpms).At this time, a malfunction of the console reportedly occurred.After the user fully turned the rpm control knob to zero, and then turned the knob back up, it was reported that no rpms were displayed and the pump motor head showed no signs of spinning.A medtronic hand crank device was immediately implemented and once the pump head was inserted, pump flow was manually restored to the patient.After the patient blood flow was considered manually sustainable, the console was rebooted by turning the power off and back on.After restarting, rpms were displayed and the empty edm pump motor head was spinning.The pump head was removed from the hand crank device and reinstalled into the edm, after which bypass was (electronically) fully resumed.The patient blood flow was manually provided for approximately 60 seconds while the console was being rebooted.It was reported that extubation was carried out normally, the patient recovery was normal, and that the patient was subsequently discharged.

Event Description

Medtronic received information that on the third attempt to terminate bypass surgery, the 560 bio-console was brought down first to a half and then to a quarter flow.At that time, the cardiotomy reservoir level sensor alarm tripped, which automatically activated the arterial line (auto) clamp.In order to reopen the autoclamp, the perfusionist turned the rpms to zero and then back up to greater than 2000 revolutions per minute (rpms).At this time, a malfunction of the console reportedly occurred.After the user fully turned the rpm control knob to zero, and then turned the knob back up, it was reported that no rpms were displayed and the pump motor head showed no signs of spinning.A medtronic hand crank device was immediately implemented and once the pump head was inserted, pump flow was manually restored to the patient.After the patient blood flow was considered manually sustainable, the console was rebooted by turning the power off and back on.After restarting, rpms were displayed and the empty edm pump motor head was spinning.The pump head was removed from the hand crank device and reinstalled into the edm, after which bypass was (electronically) fully resumed.The patient blood flow was manually provided for approximately 60 seconds while the console was being rebooted.It was reported that extubation was carried out normally, the patient recovery was normal, and that the patient was subsequently discharged.

Manufacturer Narrative

The reported event could not be duplicated during functional testing of the instrument by medtronic technical service.Multiple tests were conducted with no faults detected.Review of the instrument event data log by a medtronic engineer was unable to identify any indications of a product performance issue.Based on the information provided by the event data, the instrument may have performed as expected.The ifu states that the bio-console speed control (rpm) knob should be turned to 0 for a minimum of 1 second to reset the motor controller and open the auto-clamp.According to the event log, the rpm knob was turned down to 0 and then turned to >2000 rpm.It cannot be verified whether or not the user waited for the required 1 second before turning the rpm knob back on because the instrument only records information every 5 seconds.However, this is a plausible explanation for the reported event, supported by the fact that it could not be duplicated by medtronic service.Review of instrument device history record also did not indicate any anomalies.The investigation did not conclusively identify the cause for the reported event.(b)(4).

Manufacturer Narrative

The instrument has been returned to medtronic (b)(4) technical service for evaluation.The analysis is ongoing and has not yet been completed.Upon completion of the analysis and investigation, a supplemental report will be filed.(b)(4).

Manufacturer Narrative

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

• 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): MEDTRONIC STRUCTURAL HEART; 8200 coral sea street ne; mounds view MN 55112
• Manufacturer Contact: paula bixby ; 8200 coral sea street ne; mounds view, MN 55112 ; 7635055378
• MDR Report Key: 3961734
• MDR Text Key: 4622024
• Report Number: 2184009-2014-00058
• Device Sequence Number: 1
• Product Code: DWA
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K070286
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility,Company Representative,company represent
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 08/13/2014

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 Model Number: 560BCS1
• Device Catalogue Number: 560BCS1
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/18/2014
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/13/2014
• Initial Date FDA Received: 07/28/2014
• Supplement Dates Manufacturer Received: Not provided; 08/13/2014
• Supplement Dates FDA Received: 08/21/2014; 09/14/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/17/2009
• 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