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

Model Number	96-414-140
Medical Device Problem Code	Incorrect, Inadequate or Imprecise Result or Readings (1535)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/22/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A.1.A.5.There was no known patient involvement.D.4 unique device identifier (udi) number is not available for this product as it is a class ii medical device manufactured before september 24, 2016 which is the fda compliance date to implement udi code.H11: livanova deutschland manufactures the cp5 flow sensor.After initial event evaluation, ti was concluded the sensor cannot be repaired and a replacement product will be sent.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, during priming, when the blood flow rate is 0, the cp5 flow sensor display shows 200ml to 300ml and the flow is unstable.There was no patient involvement.The display returned to normal when it was replaced it with a backup sensor.
Additional Manufacturer Narrative
A device service history review has been performed and identified that the unit was manufactured in 2016 and another event occurred in 2023 has been identified.No similar event concerning trend has been identified.The most likely root cause has been assigned to a defective flow sensor.The risk is in the acceptable region.No specific action was currently deemed necessary.Livanova will keep monitoring the market.

• Brand Name: CP5 FLOW MEASUREMENT
• Common Device Name: CONTROL, PUMP SPEED, CARDIOPULMONARY BYPASS
• 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: 20732989
• Report Number: 9611109-2024-00556
• Device Sequence Number: 12860766
• Product Code: DWA
• UDI-Device Identifier: 04033817901532
• UDI-Public: (01)04033817901532
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K011838
• 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
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 01/28/2025

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: 96-414-140
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/22/2024
• Supplement Date Received by Manufacturer: 12/30/2024
• Initial Report FDA Received Date: 11/20/2024
• Supplement Report FDA Received Date: 01/28/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/06/2016
• 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