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

Model Number 60-01-04

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/16/2019

Event Type  malfunction  

Manufacturer Narrative

There was no patient involvement.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 the device and found the cp5 positioned horizontally not conformed with the ifu requirement.According to the technician it cannot be excluded that some liquid entered the holes at the lower side of drive unit causing the reported condition.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)(4) received a report that when turning on the main power and trying to turn on a centrifugal pump 5 (cp5), an error message was displayed and an alarm sounded."cold start" procedure (rebooting) powering off/on the device did not solve the problem.After the second attempt, another error message was displayed.It was also reported that a burning smell was coming from the drive unit once the power was turned on.There was no report of patient injury.

Event Description

See initial report.

Manufacturer Narrative

The device drive unit was returned to livanova deutschland for further investigation.The error could be reproduced.The defect has been caused by ingress of fluid.Several electrical and mechanical components were affected.

• 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: 9314384
• MDR Text Key: 195747411
• Report Number: 9611109-2019-00891
• 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: 12/17/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/13/2019
• Is this an Adverse Event Report?: No
• 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: 11/18/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1