MAUDE Adverse Event Report: LIVANOVA DEUTSCHLAND CENTRIFUGAL PUMP 5 (CP5); CONTROL, PUMP SPEED, CARDIOPULMONARY BYPASS

Model Number	60-02-60
Medical Device Problem Code	Insufficient Flow or Under Infusion (2182)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/05/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Patient information was not provided.Livanova deutschland manufactures the s5 system.The incident occurred in italy.According to follow up with the customer, the cp5 stuck at 1000 rpm at 1 l/min flow.The flow remained at 1 l/min for 12-13 minutes.The perfusionist manager has analyzed the s5 connect and cannot rule out that an excessively low-pressure alarm threshold (32 mmhg) had been set.The customer performs maintenance activity on the s5 system autonomously, livanova performed maintenance activity last time in april 2017.A livanova field service representative was dispatched to the facility to investigate the device and could not confirm the reported issue.A complete check of the cp5 system was carried out and no anomaly was found.Complete serial read-out (real time device parameters and setting recording file) of the cp5 system (control panel, centrifugal driver and flow sensor) was extracted and analysis revealed no error message stored in the day of the event.Sensor checks were conforming.Preventive maintenance was also carried out: internal and external cleaning of the s5 system (presence of dust in all devices noted), spare parts (battery kit, extension green switch, spacers pump modules, double head pump covers) have been replaced according to preventive maintenance.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 the de-clamping phase, a centrifugal pump 5 (cp5) went into protection and it was not possible to go beyond 1000 rpm in the revolution pump by activating the control knob.Patient was affected and has undergone ecmo support until (b)(6), 2023 when was patient was weaned.
Event or Problem Description
See initial report.
Additional Manufacturer Narrative
H10: correct model and serial number of the involved centrifugal pump 5 (cp5) have been added to section d of this report.Furthermore, the data collected by the connect system which records events that occurred during the procedure was also extracted and analyzed.The sequence of events agrees with a scenario in which the unit was in an alarm situation with "rampdown" mode active.Complaints database analysis revealed that no similar event on this device occurred since its installation in 2015 in addition, a review of all similar complaints worldwide was performed and no adverse trends were identified.Based on the data collected and the results of the investigation, the cause of the reported event can be traced back to the setting of the "rampdown" mode which, following the overcoming of the set pressure threshold, caused the pump speed to be automatically reduced to minimal.

• Brand Name: CENTRIFUGAL PUMP 5 (CP5)
• 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: 16663419
• Report Number: 9611109-2023-00135
• Device Sequence Number: 5933785
• Product Code: DWA
• UDI-Device Identifier: 04033817901006
• UDI-Public: (01)04033817901006(11)150814
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• 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
• Type of Report: Initial,Followup
• Report Date (Section B): 03/06/2023
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: 60-02-60
• 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: 03/06/2023
• Supplement Date Received by Manufacturer: 05/15/2023
• Initial Report FDA Received Date: 04/03/2023
• Supplement Report FDA Received Date: 06/13/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/14/2015
• 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
• Patient Sequence Number: 1
• Patient Sex: Male
• Patient Weight: 90 KG