MAUDE Adverse Event Report: LIVANOVA DEUTSCHLAND CENTRIFUGAL PUMP 5 (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	06/13/2022
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 livingston, new jersey.A livanova field service representative was dispatched to the facility to investigate the device and could not find any issue on the device.The unit was working within specifications.The drive unit was initially found to be unplugged from the panel.The driver was plugged in correctly and no issues occurred.The only way to reproduce the reported error was unplugging the drive from panel.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 deutschland received a report that a centrifugal pump 5 (cp5) gave a motor control failure error message during installation.There was no patient involvement.
Additional Manufacturer Narrative
H.10: through follow-up communication livanova learned device model and serial numbers which have been added to the dedicated d.4 section.Manufacturing date of device has been updated accordingly since it was incorrectly stated in section h.4.In addition, it was learnt that the centrifugal pump system was installed in december 2021 and no issues were detected during the installation.During the set-up for the first use, the motor control failure occurred.Taking into account that no hardware malfunctions were detected by the livanova field service technician on site and based on collected information, the most likely root cause of the reported motor control failure is an incorrect connection between the cp5 drive unit and the cp5 control panel, which has led to a disconnection of the drive unit cable from the panel, resulting in a motor control failure error.
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 80309 ; GM 80309
• Manufacturer Contact: enrico greco ; 14401 w. 65th way; arvada, CO 80004
• MDR Report Key: 14955309
• Report Number: 9611109-2022-00331
• Device Sequence Number: 6896321
• Product Code: DWA
• UDI-Device Identifier: 04033817901006
• UDI-Public: (01)04033817901006(11)211214
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• 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): 07/07/2022

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: 06/13/2022
• Supplement Date Received by Manufacturer: 07/27/2022
• Initial Report FDA Received Date: 07/08/2022
• Supplement Report FDA Received Date: 08/26/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/14/2021
• 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