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

Model Number 60-00-60Z

Device Problem Pumping Stopped (1503)

Patient Problem Insufficient Information (4580)

Event Date 12/27/2022

Event Type  Death  

Event Description

Livanova deutschland received a report that a centrifugal pump 5 drive unit (cp5) stopped during procedure.The customer had to switch it out.Patient died.

Manufacturer Narrative

Livanova deutschland manufactures the centrifugal pump 5 (cp5) drive unit.The incident occurred in (b)(6).Through follow-up communication, livanova learned that the cp5 stopped pumping during procedure after 1:30 hour and did not show any alarms.The customer had to switch it out with a centrifugal pump console (scpc) and it worked fine.Then the customer ran the cp5 for three hours after the case and it ran fine.Moreover, the facility said that the event was due to a user error: pressure settings were too low for the flow rate requested and therefore flow went to detent setting.Function verified corrected by biomed after setting pressure values to appropriate for four lpm flow.If any additional information pertinent to the reported event is received, it will be provided in a supplemental report.

• Brand Name: CENTRIFUGAL PUMP 5
• Type of Device: CONTROL, PUMP SPEED, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): LIVANOVA DEUTSCHLAND; lindberghstrasse 25; munich 80939
• MDR Report Key: 16245251
• MDR Text Key: 308143412
• Report Number: 1718850-2023-01003
• 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: Distributor
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 01/26/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/26/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 60-00-60Z
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 12/27/2022
• Device Age: 9 MO
• Event Location: Hospital
• Date Manufacturer Received: 12/27/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Death