MAUDE Adverse Event Report: LIVANOVA DEUTSCHLAND GMBH CENTRIFUGAL PUMP 5 (CP5); CONTROL, PUMP SPEED, CARDIOPULMONARY BYPASS

Model Number 60-01-04

Device Problem Pumping Stopped (1503)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/29/2019

Event Type  Injury  

Manufacturer Narrative

Patient information was not provided.Livanova (b)(6) manufactures the centrifugal pump 5 (cp5).The incident occurred in (b)(6).Livanova initiated an investigation.A review of the dhr did not identify any deviations or non-conformities relevant to the reported issue.If any additional information pertinent to the reported event is received, it will be provided in a supplemental report.

Event Description

Livanova (b)(6) received a report that a patient with coronary heart disease underwent coronary bypass surgery.During the procedure with the heart already pinched and drained, it was requested to fill the heart to measure a saphenous bridge (routine procedure).The centrifugal pump 5 (cp5) decreased the speed to 1000 rpm and the flow became almost zero.The perfusionist tried to restart the pump 3 times without success while he was waiting for a backup unit to continue the procedure.While saphenous bridge measures were taken, the patient was out of circulation (unemployment) for a period of 3-5 minutes.After restarting, perfusion proceed to cool for approximately 40 minutes for brain protection.The patient wakes up approximately 6 hours later without any deficit.He is discharged without complications.

Event Description

See initial report.

Manufacturer Narrative

H.10: a review of the dhr did not identify any deviations or non-conformities relevant to the reported issue.Differently from what initially stated, through follow-up communication livanova learned that the centrifugal pump 5 (cp5) decreased the speed to about 1000 rpm.The perfusionist tried to reset the pump 3 times without success while he was waiting for a backup unit to continue the procedure.Through further follow-up communication livanova learned that the user had clamped the arterial line.This likely increased the pressure in the centrifugal pump system leading to a pressure alarm.A livanova field service representative was dispatched to the facility and tested the device which was found to be properly working.Subsequent functional verification testing was completed without further issues and the unit was returned to service.The serial read-out has been analyzed and two occurrences of error 451 (index impulse missing) were found stored in the microcontroller in the date of the event 29.11.2019.The control panel has not been made avilable for furthe investigation since it is in use at the customer site.However, the 451 error was most likely caused by the user disconnecting the cable between the panel and the drive unit with the panel still powered on.The customer informed livanova that the ramp-down function had been activated.When this feature is activated, in case a bubble/level/pressure alarm is triggered, the centrifugal pump automatically decreases its speed to the lower set value.Normally, the pump speed increases again once the alarm condition is restored.In this specific case, it is likely that the user did not manage properly the above mentioned pressure alarm situation.Indeed, livanova has been informed that the perfusion personnel was trained again in the management of alarms and supervisions of the centrifugal pump system.

• Brand Name: CENTRIFUGAL PUMP 5 (CP5)
• Type of Device: CONTROL, PUMP SPEED, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): LIVANOVA DEUTSCHLAND GMBH; lindberghstr. 25; munich
• MDR Report Key: 9534411
• MDR Text Key: 188485042
• Report Number: 9611109-2019-01023
• Device Sequence Number: 1
• Product Code: DWA
• Combination Product (y/n): N
• PMA/PMN Number: K112225
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 02/27/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/31/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 60-01-04
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/04/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1