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

Model Number	25-60-70
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	05/30/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A.1.-a.5.Patient information were not provided.H10: livanova deutschland manufactures the flow sensor measurement.The incident occurred in united states.A livanova field service engeneet was dispatched to the customer and found the flow sensor and the flow module were out of tolerance.They have been replaced.Performed flow test performance passed.Performed all functional checks per tsi system is functional and ready for use.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 has received a report that, during a procedure, patient blood flow will not correlate when the rpm maxs out.There was no patient injury.
Additional Manufacturer Narrative
H10: complaints database analysis revealed no similar event since unit installation in 2019.It cannot be ruled out that the root cause of the reported event was a defective flow sensor and module due to wear.

• Brand Name: CP5 FLOW MODULE
• Common Device Name: CONTROL, PUMP SPEED, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): LIVANOVA DEUTSCHLAND GMBH; 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: 17225143
• Report Number: 9611109-2023-00293
• Device Sequence Number: 15255739
• Product Code: DWA
• UDI-Device Identifier: 04033817900733
• UDI-Public: (01)04033817900733(11)190401
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K112225
• 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): 06/29/2023

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: 25-60-70
• 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: 05/30/2023
• Supplement Date Received by Manufacturer: 07/28/2023
• Initial Report FDA Received Date: 06/29/2023
• Supplement Report FDA Received Date: 08/25/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/01/2019
• 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