MAUDE Adverse Event Report: LIVANOVA DEUTSCHLAND CENTRIFUGAL PUMP CONSOLE; PUMP, BLOOD, CARDIOPULMONARY BYPASS, NON-ROLLER TYPE

Model Number 60-03-00

Device Problem Device Displays Incorrect Message (2591)

Patient Problem No Patient Involvement (2645)

Event Date 02/05/2018

Event Type  malfunction  

Manufacturer Narrative

Livanova (b)(4) manufactures the centrifugal pump console.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 not returned.

Event Description

Livanova (b)(4) received a report that a centrifugal pump system displayed an error message during priming.There was no patient involvement.

Event Description

See initital report.

Manufacturer Narrative

The serial number provided in the initial report, submitted march 2, 2018, was incorrect.The correct serial number is (b)(4).

Manufacturer Narrative

A livanova field service representative was dispatched to the facility to investigate.The service representative was not able to confirm or to reproduce the reported issue.The device worked according the specification.Further it was found that no one at customer side could confirm that an issue occurred.

• Brand Name: CENTRIFUGAL PUMP CONSOLE
• Type of Device: PUMP, BLOOD, CARDIOPULMONARY BYPASS, NON-ROLLER TYPE
• Manufacturer (Section D): LIVANOVA DEUTSCHLAND; lindberghstr. 25; munich 80939 ; GM 80939
• MDR Report Key: 7309997
• MDR Text Key: 101602358
• Report Number: 9611109-2018-00168
• Device Sequence Number: 1
• Product Code: KFM
• Combination Product (y/n): N
• PMA/PMN Number: K020571
• 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,Followup
• Report Date: 10/15/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/02/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 60-03-00
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 09/19/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1