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

Model Number 60-02-60

Device Problem Device Displays Incorrect Message (2591)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/11/2018

Event Type  malfunction  

Manufacturer Narrative

Livanova (b)(4) manufactures the centrifugal pump 5.The incident occurred in (b)(6).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.Device was not returned.

Event Description

Livanova (b)(4) received a report that a centrifugal pump 5 displayed an error message during procedure.There was no report of patient injury.

Manufacturer Narrative

Photographs of the event were provided by the customer, confirming the reported issue.During the investigation, livanova (b)(4) learned that a high-frequency surgery device was in use during the case.After inspection of the photos and evaluation of the reported event details, it was determined that the event was caused by a system reaction due to an internal firmware malfunction.The firmware malfunction may have been caused by irritation by high-frequency energy due to the use of a high-frequency instrument during the case.A livanova field service representative performed measures to improve the emc safety of the involved device and reported at that time that the device was working without faults.

• Brand Name: CENTRIFUGAL PUMP 5
• Type of Device: CONTROL, PUMP SPEED, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): LIVANOVA DEUTSCHLAND; lindberghstr. 25; munich 80939 ; GM 80939
• MDR Report Key: 7250576
• MDR Text Key: 99830767
• Report Number: 9611109-2018-00088
• 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: 08/20/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/08/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: 60-02-60
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 07/24/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1