MAUDE Adverse Event Report: LIVANOVA DEUTSCHLAND GMBH LIVA NOVA CP5; CONTROL, PUMP SPEED, CARDIOPULMONARY BYPASS

Model Number 60E02686

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 04/19/2024

Event Type  malfunction  

Event Description

Centrifugal pump failure prior to cardiopulmonary bybass.Staff immediately told the surgeon the issue and clamped my lines to troubleshoot the issue.The alarm disappeared, and the pump was working again.We changed out the pump and pump head from the disposable, tested the new pump and recirculated the blood for a few minutes as well as flashed the lines connected to the patient.

• Brand Name: LIVA NOVA CP5
• Type of Device: CONTROL, PUMP SPEED, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): LIVANOVA DEUTSCHLAND GMBH
• MDR Report Key: 19174006
• MDR Text Key: 341076543
• Report Number: MW5154164
• Device Sequence Number: 1
• Product Code: DWA
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 04/20/2024

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
• Device Operator: Health Professional
• Device Model Number: 60E02686
• Device Catalogue Number: 48E01919
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 04/23/2024
• Patient Sequence Number: 1
• Patient Age: 59 YR
• Patient Sex: Female