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

Model Number	60-02-60
Medical Device Problem Code	Pumping Stopped (1503)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/16/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A.1.-a.5.Patient information was not provided.H11: livanova deutschland manufactures the cp5 roller pump.The incident occurred in united states.Through follow-up with the customer, livanova was that informed all of the pumps lost power simultaneously and then displayed an error code which was never documented.The bio-med also stated that this was the second time this has occurred with this machine.Based on this information, it can be suggested that is a centralized problem with the ep-pack if it is impacting all of the pumps simultaneously.Customer swapped the ep-pack with his spare parts livanova field service performed the preventive maintenance and unit functioned within specifications.System firmware updated and unit returned to service.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, cp5 pump control panel lost set parameters causing rpms to fall to zero, set coast speed of 1300rpms was not achieved resulting in retrograde.Several errors populated during the event.There is no report of any patient injury.
Additional Manufacturer Narrative
The electronics / and power pack is located inside the console.The console was manufactured in 2010 and no other similar events have been recorded since its installation.Therefore, the e/p pack that comprises the power-supply components (including the emergency power supply), had never been replaced before the complained event.Postmarket data analysis didn't identify any similar complaints concerning trend.Based on above, it cannot be ruled out that the reported condition was caused by an electronic failure of the ep-pack.The wearing of electro-mechanical device can be originated by the specific use condition at customer site and may have contributed to the event, however there is no concerning trend for this kind of failure.No other specific action was currently deemed necessary, livanova maintains and documents periodic customer events monitoring process in order to evaluate actions for products improvement.

• Brand Name: CP5
• Common Device Name: CONTROL, PUMP SPEED, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): LIVANOVA DEUTSCHLAND GMBH; lindberghstrasse 25; munich
• Manufacturer (Section G): LIVANOVA DEUTSCHLAND GMBH; lindberghstrasse 25; munich
• Manufacturer Contact: enrico greco ; 14401 w. 65th way; arvada, CO 80004
• MDR Report Key: 19542355
• Report Number: 9611109-2024-00254
• Device Sequence Number: 7501374
• Product Code: DWA
• UDI-Device Identifier: 04033817901006
• UDI-Public: (01)04033817901006(11)180321
• Combination Product (Y/N): N
• Initial Reporter State: MO
• 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
• Initial Reporter Occupation: Other
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 08/26/2024

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
• Operator of Device: Health Professional
• Device Model Number: 60-02-60
• 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: 05/16/2024
• Supplement Date Received by Manufacturer: 07/28/2024
• Initial Report FDA Received Date: 06/14/2024
• Supplement Report FDA Received Date: 08/26/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/21/2018
• 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