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

Model Number 560BCS1

Device Problem Device Displays Incorrect Message (2591)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 03/24/2014

Event Type  Injury  

Event Description

Medtronic received information reporting that after being on bypass for nearly 57 minutes, the high level alarm on the 560 bio-console was triggered, shutting down the external drive motor.The health care professional (hcp) believed that the high level alarm had not been turned on.The perfusionist clamped the venous and arterial lines and reset the high volume alert alarm as well as the bio-console.The perfusionist reported the entire process only took a few seconds and the patient was never compromised.The bio-console was used to successfully complete the case without further issues.It was noted that because of the patient's large body surface area, 3 liters of volume had already been taken off when bypass was started.During normal flow ( i.E.2.4- 2.6 cardiac index for his current temperature) the total bypass circuit needed to hold about 1/3 of the patient's total blood volume, which in this case was almost 10 liters ((b)(6)), so the perfusionist stated there were over 3.3 liters of volume in the reservoir at all t imes.

Manufacturer Narrative

Upon receipt at medtronic¿s quality laboratory, the event log for the bio-console was reviewed.The customer had stated in their initial event narrative that the upper level sensor was turned off, but the event log showed that at the time of the event the bio-console and upper level sensor had been set to action 2 (2=when low level is detected by sensor, stop motor).The event log from the instrument showed that the upper level sensor properly detected low levels at time 1100:46:22 and stopped the motor as programmed.The user initially attempted to turn the rpm (revolutions per minute) to maximum, but after the motor has stopped the instrument requires that the rpm knob be reset to zero before turning it back up.The user turned the rpm knob to zero at time 1100:47:48 and then resumed rpm and flow.The total time from motor stop to restart was one minute and thirty seconds.The event log showed that after the case the user changed the upper level sensor action from ¿stop motor¿ to ¿alert¿.Following the review of the instrument¿s event log, the medtronic service technician functionally tested the bio-console.The instrument performed normally with no anomalies observed.Medtronic¿s quality engineers confirmed the timeline of events described by the customer, but review of the bio-console memory log showed that the device had not malfunctioned.The level sensor and bio-console performed as programmed, stopping the motor.After one minute and thirty seconds, the user re-established flow and the case was completed successfully with no adverse patient effects.(b)(4).

Event Description

Medtronic received information reporting that after being on bypass for nearly 57 minutes, the high level alarm on the 560 bio-console was triggered, shutting down the external drive motor.The health care professional (hcp) believed that the high level alarm had not been turned on.The perfusionist clamped the venous and arterial lines and reset the high volume alert alarm as well as the bio-console.The perfusionist reported the entire process only took a few seconds and the patient was never compromised.The bio-console was used to successfully complete the case without further issues.It was noted that because of the patient's large body surface area, 3 liters of volume had already been taken off when bypass was started.During normal flow ( i.E.2.4- 2.6 cardiac index for his current temperature) the total bypass circuit needed to hold about 1/3 of the patient's total blood volume, which in this case was almost 10 liters (132 kg x 75 ml/kg), so the perfusionist stated there were over 3.3 liters of volume in the reservoir at all times.

Manufacturer Narrative

The bio-console has been received by medtronic's quality laboratory and analysis is currently in process.Upon completion of analysis, 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: 3761516
• MDR Text Key: 4619744
• Report Number: 2184009-2014-00023
• 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 Facility,Company Representative,company representati
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 03/24/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/21/2014
• Is this an Adverse Event Report?: No
• 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: 04/08/2014
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/24/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/17/2012
• 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 Weight: 132