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

Model Number	SRD S5 CONSOLE FOR 4 PUMP
Medical Device Problem Code	Complete Loss of Power (4015)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/05/2025
Type of Reportable Event	Malfunction
Event or Problem Description
Livanova deutschland received a report that the cp5 on hlm powered off during case.Medical team powered it back on and worked again and were able to complete the case.There is no report of any patient injury.
Additional Manufacturer Narrative
A1 to a5: patient information were not provided.H11: livanova deutschland manufactures the cp5.If any additional information pertinent to the reported event is received, it will be provided in a supplemental report.
Additional Manufacturer Narrative
H11: a livanova field service engineer (fse) was dispatched to the facility to investigate the device.A crack was found out at the base of centrifugal pump drive, however, during functional tests, no power cycle of the centrifugal pump occurred, thus reported condition was not reproduced.If any additional information pertinent to the reported event is received, it will be provided in a supplemental report.
Event or Problem Description
See initial report.
Additional Manufacturer Narrative
A device service history review has been performed and identified that the unit was manufactured in 2018 and no other similar event has been reported.No adverse trend was detected concerning this failure mode.Taking into account that no further event occurred during the procedure, and considering that no part replacement was required, it cannot be ruled out that the most likely root cause of complained event was a temporary internal electrical failure as a false contact or bad connections which was definitively fixed by service technician throughout the equipment check.The risk is in the acceptable region.No specific action was currently deemed necessary.Livanova will keep monitoring the market.
Event or Problem Description
See initial report.

• Brand Name: CP5
• Common Device Name: CONTROL, PUMP SPEED, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): LIVANOVA DEUTSCHLAND GMBH; lindberghstrasse 25; munich 80939 ; GM 80939
• Manufacturer (Section G): LIVANOVA DEUTSCHLAND; lindberghstrasse 25; munich 80939 ; GM 80939
• Manufacturer Contact: annarita di lascio ; 14401 w. 65th way; arvada, CO 80004
• MDR Report Key: 22084732
• Report Number: 9611109-2025-90141
• Device Sequence Number: 18109537
• Product Code: DWA
• UDI-Device Identifier: 04033817900894
• UDI-Public: (01)04033817900894(11)180601
• Combination Product (Y/N): N
• PMA/510(K) Number: K112225
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other
• Remedial Action: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 04/30/2026

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: SRD S5 CONSOLE FOR 4 PUMP
• Device Catalogue Number: 48-40-00
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/05/2025
• Supplement Date Received by Manufacturer: 05/27/2025; 03/31/2026
• Initial Report FDA Received Date: 05/26/2025
• Supplement Report FDA Received Date: 11/20/2025; 04/30/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/04/2023
• 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