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

Model Number 60-01-04

Device Problem Pumping Stopped (1503)

Patient Problem Infarction, Cerebral (1771)

Event Type  malfunction  

Manufacturer Narrative

Patient information was not provided.The date of event has not been provided yet.If this information is provided it will be provided in a supplemental report.Livanova (b)(4) manufactures the centrifugal pump 5 (cp5).The incident occurred in (b)(6).A livanova field service representative was dispatched to the facility to investigate but he could not reproduce the reported failure.He tested the unit and it was working within specifications.However, under customer request, a new device was installed.Through follow-up communication with the technician in charge, livanova (b)(4) learned that the patient did suffer a stroke during the surgery.It is unclear as to whether the incident could be or not a contributing factor of the stroke.Patient was transferred from icu and is recovering from the negative symptoms.The serial read-out of the pump has been collected and the affected device was requested back to the manufacturer site for a detailed investigation.If any additional information pertinent to the reported event is received, it will be provided in a supplemental report.

Event Description

Livanova (b)(4) received a report that the display of a centrifugal pump 5 (cp5) became blank and the device stopped working during the procedure resulting in blood having a dark color.The surgeon decided to abort the bypass and to end the procedure prematurely.

Event Description

See initial report.

Manufacturer Narrative

The results of the investigation at the manufacturer site revealed that the issue could not be reproduced.The device was found to be working within specifications.

• Brand Name: CENTRIFUGAL PUMP 5 (CP5)
• Type of Device: CONTROL, PUMP SPEED, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): LIVANOVA DEUTSCHLAND; lindberghstr. 25; munich
• MDR Report Key: 8780364
• MDR Text Key: 150695834
• Report Number: 9611109-2019-00527
• 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: 09/13/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/11/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 60-01-04
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 08/16/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening; Required Intervention