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	01/14/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
There was no patient involvement.Livanova (b)(4) manufactures the centrifugal pump 5 (cp5).The incident occurred in (b)(6).Livanova initiated an investigation.If any additional information pertinent to the reported event is received, it will be provided in a supplemental report.
Event or Problem Description
Livanova (b)(4) received a report that during extracorporeal circulation, the cp5 control panel blacked out shortly after the a timeout alarm between the cp5 and the arterial clamp.Reportedly the pump stopped during timeout error.The control panel was turned off and back on and the issue improved.The procedure was completed with no further issues.There was no report of patient injury.
Event or Problem Description
See initial report.
Additional Manufacturer Narrative
The reported error message related to the timeout of the erc clamp indicated that the communication between the erc and the cp5 system has been interrupted.This can occur in case the cp5 panel lost its can-connection, consequently leading to the cp5 reported black-out, too.The serial read-out (real time device parameters and setting recording file) of the cp5 control panel was gathered and analyzed.No events are stored in the cp5 microprocessor in the reported date of the event.If the panel losts the can connection and is not power supplied anymore, no error message / code are stored in the microcontroller.Based on the investigation performed for similar cases, the lost can-connection of the cp5 control panel can be the result of a defective processor board.A livanova field service technician was dispatched to the customer facility and the cp5 system was checked.No deviations were detected during functional tests.The processor board was replaced as potentially involved component.Subsequent functional verification testing was completed without further issues and the unit was returned to service.The involved cp5 control panel was manufactured in 2016 and according to the analysis of the complaints database no similar events have been reported in the past.Taking into account all the above information, the root cause of the reported event was traced back to an intermittent malfunction of the processor board.

• 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: 13531671
• Report Number: 9611109-2022-00065
• Device Sequence Number: 5115105
• Product Code: DWA
• UDI-Device Identifier: 04033817901006
• UDI-Public: (01)04033817901006(11)160229
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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): 02/13/2022

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: 01/17/2022
• Supplement Date Received by Manufacturer: 02/28/2022
• Initial Report FDA Received Date: 02/15/2022
• Supplement Report FDA Received Date: 03/30/2022
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/29/2016
• 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