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

Model Number	60-02-60
Medical Device Problem Code	No Flow (2991)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/30/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
There was no patient involvement.Livanova deutschland manufactures the centrifugal pump 5 (cp5).The incident occurred in (b)(6).A livanova field service representative was dispatched to the facility to investigate the device and could not reproduce the reported problem.Machine worked through a wide range of settings.Flow sensor and module read values exactly as referenced values on calibrated flow meter from 1 lpm to 8 lpm.Rpms were measured with calibrated tachometer and matched set values.All modes functioned correctly and alarms sounded when triggered.Subsequent functional verification testing was completed without further issues and the unit was 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 received report of getting back flow (negative flow) from patient prior to starting the procedure during testing of the circuit, even if centrifugal pump 5 (cp5) was set to 1500 rpms.Cp5 alarmed immediately at the negative flow level and clamped the line.Perfusionist observed that the revolution head was spinning, but could not identify why no positive flow could be achieved.Ultimately decided to switch to a backup pump with a new patient circuit.Procedure was accomplished without patient impact.Second perfusionist tested the machine and patient circuit that had issue after the procedure and could not reproduce the reported issue and wanted the machine to be checked by a service technician.There was no patient involvement.
Additional Manufacturer Narrative
Livanova received report of getting negative flow from patient prior to starting the procedure during testing of the circuit.Cp5 alarmed immediately.Medical team elected to switch to a backup pump with a new patient circuit.The unit was returned to service.Based on field service activity and considering that no similar event since unit installation in 2017 was logged in livanova complaint database, it was possible to exclude a hardware failure of the cp5 and related flow sensor.Therefore, the most likely root cause of the reported event was caused by an event related to procedure and/or patient clinical conditions.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: 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: 15679560
• Report Number: 9611109-2022-00552
• Device Sequence Number: 6462321
• Product Code: DWA
• UDI-Device Identifier: 04033817901006
• UDI-Public: (01)04033817901006(11)171114
• Combination Product (Y/N): N
• Initial Reporter State: AK
• 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 Health Care Professional
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 01/19/2023

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: 60-02-60
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/30/2022
• Supplement Date Received by Manufacturer: 12/20/2022
• Initial Report FDA Received Date: 10/27/2022
• Supplement Report FDA Received Date: 01/19/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/14/2017
• 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