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

Model Number 48-20-00

Device Problem Decreased Pump Speed (1500)

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

Event Date 11/10/2023

Event Type  malfunction  

Event Description

Livanova deutschland received a report that during procedure speed of a cp5 console dropped to 1000 rpm, which is the minimum threshold with no alarm showing.Speed was then tried to be increased, however there was no response from the cp5 control panel.System was rebooted and the issue was still present.There was no patient injury.

Manufacturer Narrative

A.1.-a.5.There was no patient involvement.H10: livanova deutschland manufactures the cp5 console.The incident occurred in houston, texas.Through follow-up communication livanova learned that pressure threshold was set to zero by the customer.Therefore, when the pressure went below zero it would start to ramp down the rpm and not alarm.If any additional information pertinent to the reported event is received, it will be provided in a supplemental report.

Manufacturer Narrative

Additional information has been requested and it has been revealed that the cp5 acts as per expectation and no alarm was requested based on additional information confirmed by the field service engineer, the event has been re-evaluated as not reportable event as the device acts as expected.

• Brand Name: CP5 CONSOLE
• Type of Device: CONTROL, PUMP SPEED, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): LIVANOVA DEUTSCHLAND; lindberghstrasse 25; munich
• Manufacturer (Section G): LIVANOVA DEUTSCHLAND; lindberghstrasse 25; munich
• Manufacturer Contact: enrico greco ; 14401 w. 65th way; arvada, CO 80004
• MDR Report Key: 18281758
• MDR Text Key: 329901638
• Report Number: 9611109-2023-00624
• Device Sequence Number: 1
• Product Code: DWA
• 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 Health Care Professional
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 01/04/2024

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: 48-20-00
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 11/10/2023
• Initial Date FDA Received: 12/07/2023
• Supplement Dates Manufacturer Received: 01/04/2024
• Supplement Dates FDA Received: 01/04/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/07/2023
• 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