MAUDE Adverse Event Report: PERFUSION SYSTEMS CONSOLE 560BC1 CONTROLLER W/O SAFETY BRD; CONTROL, PUMP SPEED, CARDIOPULMONARY BYPASS

Model Number 560BC1

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/11/2017

Event Type  Injury  

Manufacturer Narrative

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 that during a bypass procedure the low blood level alarm on the bio-console was triggered when the level sensor detached from the side of the blood reservoir.The low blood level alarm on the instrument was set to ¿stop¿, which halted the centrifugal pump and positive flow of blood within the perfusion circuit.The perfusionist stated that the settings on the instrument would normally be set to trigger an audible alert and a change to ¿coast¿ mode (2,000 rpm) instead of ¿stop", but they had been changed without the users knowledge.As the perfusionist turned the rpm control knob to zero to reset the instrument and reinitiate flow, they observed that there was -0.4 l/min.Of backflow.The user estimated that this period of backflow continued for 30 seconds.The aortic root and left ventricular vents were activated, which entrained air into the circuit from the surgical field.While intraoperative transesophageal echocardiography (tee) did not verify intracardiac air, the patient subsequently developed an episode of ventricular fibrillation.The patient was put into deep trendelenburg for approximately thirty minutes while keeping the mean arterial pressure (map) in the eighties.The cerebral saturation, which had dipped to 20 on the right side and 30 on the left side, increased with the resumption of flow to levels observed prior to the event.The patient was successfully weaned from bypass.Post-operative ct scans confirmed that there was no evidence of neurologic injury related to air embolism.

Manufacturer Narrative

The report of the bio-console¿s audible alarm was confirmed and resolved under a similar report by replacement of the user interface controller board and the bitsy xb computer module.In this occurrence, the customer stated the safety system settings were changed on the bio-console without the perfusionist¿s knowledge.Chapter 6 of the operator and reference manual (instructions for use) addresses the safety systems and includes the caution statement ¿the performance of the safety systems must be verified before each use.¿ a clinical review of this event concluded: the outcome of this event was compounded by the user being unaware of the level sensing system response settings during the case.There are no new risks associated with the use of the bio-console 560 as no new failure modes or use conditions of the system have been observed.A review of bio-console 560 complaints received from (b)(6) 2012 through (b)(6) 2018 was conducted; the observed field performance is aligned with the predicted field performance.The operator¿s manual instructs the user to verify the safety systems will respond appropriately prior to each use and provides instructions for verifying the safety systems.No additional actions necessary.All reported complaints for this product are monitored and trended.If information is provided in the future, a supplemental report will be issued.

• Brand Name: CONSOLE 560BC1 CONTROLLER W/O SAFETY BRD
• 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: 7051030
• MDR Text Key: 92716483
• Report Number: 2184009-2017-00044
• Device Sequence Number: 1
• Product Code: DWA
• 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: health professional,user faci
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 04/06/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/21/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 560BC1
• Device Catalogue Number: 560BC1
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 03/26/2018
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 09/22/2012
• 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