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

Model Number	60-03-00
Medical Device Problem Code	Pumping Stopped (1503)
Health Effect - Clinical Codes	Shock (2072); Coma (2417); Ischemia Stroke (4418)
Date of Event	09/12/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A.1.-a.5.Patient information was not provided.H10: livanova deutschland manufactures the centrifugal pump console.The incident occurred in (b)(6), china.Through follow-up communication livanova learned that after returning to the hospital, another equipment to support the patient was immediately used.Therefore, there was no interruption of blood flow.Moreover, it was learned that the direct reason of patient death was the critical condition of the patient himself.Clinical patient history: years of diabetes.While transferring, the patient was diabetic keto acidosis and lactic acidosis, coma, shock, respiratory failure, acute renal insufficiency and hypoxic-ischemic encephalopathy have been reported clinically.Therefore, patient death is considered non-device related by health professional responsible for care (hcp).After subsequent maintenance by authorized technician, the main circuit (cpu) board on the control panel was confirmed faulty.The device was repaired after replacing this board.If any additional information pertinent to the reported event is received, it will be provided in a supplemental report.
Event or Problem Description
Livanova deutschland received a report that a centrifugal pump console gave an error code associated to shaft angle encoder defective and the centrifugal pump stopped running.Then, since the failure could not be eliminated, pump hand crank was performed in time by health professional responsible for care (hcp).The issue occurred during patient ecmo transfer on the ambulance.Patient died.
Additional Manufacturer Narrative
H10: based on the collected information and on technical intervention, the root cause of the event can be traced back to a defective main circuit (cpu) board.The failure of electronic board can be related to multiple and not deterministic factors such as exposure to heat, dust and moisture, accidental impact (drops and falls), and power overloads/surges but also to the variability of micro subcomponents.However, there is no concerning trend for this kind of failure.
Event or Problem Description
See initial report.

• Brand Name: CENTRIFUGAL PUMP CONSOLE
• Common Device Name: PUMP, BLOOD, CARDIOPULMONARY BYPASS, NON-ROLLER TYPE
• Manufacturer (Section D): LIVANOVA DEUTSCHLAND; lindberghstrasse 25; munich
• Manufacturer (Section G): LIVANOVA DEUTSCHLAND; lindberghstrasse 25; munich 80939 ; GM 80939
• Manufacturer Contact: enrico greco ; 14401 w. 65th way; arvada, CO 80004
• MDR Report Key: 18130127
• Report Number: 9611109-2023-00602
• Device Sequence Number: 15348772
• Product Code: KFM
• UDI-Device Identifier: 04033817901013
• UDI-Public: (01)04033817901013(11)190613
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K020571
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 02/29/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 60-03-00
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/16/2023
• Supplement Date Received by Manufacturer: 01/31/2024
• Initial Report FDA Received Date: 11/14/2023
• Supplement Report FDA Received Date: 02/29/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/13/2019
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown