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

Model Number 48-40-00

Device Problem Pumping Stopped (1503)

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

Event Date 11/17/2023

Event Type  malfunction  

Event Description

Livanova deutschland has received a report that cp5 turned off and wouldnt turn back on during a procedure.There is no report of any patient injury.

Manufacturer Narrative

H10: livanova deutschland manufactures the cp5.The incident occurred in usa.If any additional information pertinent to the reported event is received, it will be provided in a supplemental report.

Manufacturer Narrative

Customer confirmed all connectors were checked and confirmed to seated properly.Customer also informed the centrifugal pump had also stopped.Then the s5 was powered up and it came back up and ran without any issue.A livanova field service engineer was dispacted to the customer site and confirmed the cp5 panel and pump did not appear to have any power.Connectors were reseated and this did not solve the issue.It was noticed that two (2) module cover plates were marked as having issue.The livanova field service engineer moved the cp5 to a different port in the ep pack and powered the s5 back on, and the cp5 and drive motor came back on and ran as expected.Since the most possible root cause was port on the ep pack was starting to go out, the livanova field service engeneer marked the suspected bad port to help keep track of it.Customer was recommended to replace the ep pack.However the customer has not yet taken any decision.Unit was returned to service.If any additional information pertinent to the reported event is received, it will be provided in a supplemental report.

Event Description

See initial report.

• Brand Name: CP5 CONSOLE
• Type of Device: CONTROL, PUMP SPEED, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): LIVANOVA DEUTSCHLAND GMBH; lindberghstrasse 25; munich
• Manufacturer (Section G): LIVANOVA DEUTSCHLAND GMBH; lindberghstrasse 25; munich 80309 ; GM 80309
• Manufacturer Contact: enrico greco ; 14401 w. 65th way; arvada, CO 80004
• MDR Report Key: 18319660
• MDR Text Key: 330393502
• Report Number: 9611109-2023-00638
• Device Sequence Number: 1
• Product Code: DWA
• UDI-Device Identifier: 04033817900894
• UDI-Public: 010403381790089411160713
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K112225
• 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,Followup
• Report Date: 03/25/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/13/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 48-40-00
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/29/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/13/2016
• 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