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

Model Number 60-03-75

Device Problems Unexpected Therapeutic Results (1631); No Apparent Adverse Event (3189)

Patient Problem Insufficient Information (4580)

Event Type  Death  

Manufacturer Narrative

Patient information was not provided.Livanova deutschland manufactures the centrifugal pump console.The incident occurred in united states.The livanova field service representative in charge performed functional checks.Units was tested unit for hours and no fault on the unit detected.Unit was release to the customer for use.If any additional information pertinent to the reported event is received, it will be provided in a supplemental report.

Event Description

Livanova deutschland received a report of a patient death.Due to patient outcome, the customer wanted the centrifugal pump console in use during procedure to be checked.According to information, no issues, no warnings with the centrifugal pump console, the customer stated the unit wasn¿t the cause if the patients death.

Manufacturer Narrative

A review of dhr could not identify any deviations or nonconformities relevant to the issue.The review of the complaints on the affected device has been performed, highlighting that no similar event has been registered since its installation in 2014, neither concerning for similar event.Based on the information collected, it can reasonably exclude malfunctions of the hlm machine.The risk is in the acceptable region.No specific action was currently deemed necessary.Livanova will keep monitoring the market.

• Brand Name: CENTRIFUGAL PUMP CONSOLE
• Type of Device: PUMP, BLOOD, CARDIOPULMONARY BYPASS, NON-ROLLER TYPE
• Manufacturer (Section D): LIVANOVA DEUTSCHLAND; lindberghstrasse 25; munich
• Manufacturer (Section G): LIVANOVA DEUTSCHLAND GMBH; lindberghstrasse 25; munich 80939 ; GM 80939
• Manufacturer Contact: enrico greco ; 14401 w 65th way; arvada, CO 80004
• MDR Report Key: 16204966
• MDR Text Key: 307688263
• Report Number: 9611109-2023-00032
• Device Sequence Number: 1
• Product Code: KFM
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K020571
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Other
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 06/30/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/19/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 60-03-75
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 05/31/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/22/2014
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Death
• Patient Age: 50 YR
• Patient Sex: Male
• Patient Weight: 150 KG