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

Model Number	60-00-60Z
Medical Device Problem Codes	Incorrect, Inadequate or Imprecise Result or Readings (1535); Infusion or Flow Problem (2964)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/30/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A.1.-a.5.There was no patient involvement.H10: livanova deutschland manufactures the centrifugal pump 5 (cp5).The incident occurred in dallas, texas.A livanova field service representative was dispatched to the facility to investigate the device and could confirm the reported issue.The unit had two flow modules and both were set to "dev1".All flow modules are shipped pre-programmed with being device 2.The customer wanted 2 flow modules on a unit, therefore one of them needed to be renamed to device 2 in order that it had its own label for recognition.To solve the issue and to have a flow dev 1 and flow dev2, s5 system firmware was flashed to a new version.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) was displaying an incorrect flow (flow measuring issue) during procedure.There was no patient injury.
Event or Problem Description
See initial report.
Additional Manufacturer Narrative
H10: through follow-up communication, livanova learned that the customer holds 1cp5 system that is composed by default by: 1 control panel, 1 drive unit, 1 flow sensor and , 1 flow module as per device instructions for use.In addition, the customer got an additional spare flow module.Therefore, the two flow modules were not in the same system when they were installed.This is an off label use, since it was solely caused by a user error who installed inside the e/p (electronics and power) pack two flow modules even if the system was not configured to accept two cp5 units and so two flow modules.No patient impact and no specific trend.The event has been re-assessed as not reportable.

• 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: 17216958
• Report Number: 9611109-2023-00286
• Device Sequence Number: 19591661
• Product Code: DWA
• UDI-Device Identifier: 04033817902782
• UDI-Public: (01)04033817902782(11)220517
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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): 06/28/2023

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: 60-00-60Z
• 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: 05/30/2023
• Supplement Date Received by Manufacturer: 08/08/2023
• Initial Report FDA Received Date: 06/28/2023
• Supplement Report FDA Received Date: 09/04/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/17/2022
• 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