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

Model Number	60-01-04
Medical Device Problem Codes	Decreased Pump Speed (1500); Pumping Stopped (1503)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/18/2022
Type of Reportable Event	Malfunction
Event or Problem Description
Livanova received report that when turned on and rpms increased to 2000 the pump head of centrifugal pump 5 (cp5) did not turn.The rpm number stayed yellow, then went to zero with the dial still at 2000.At this time, the pump head started to turn very slowly.The rpms were manually set down to zero and back up very slowly to 2000.The pump head still only turned slowly.The rpm number remained yellow.I watched for a few minutes and without me touching anything the pump head speed increased to match the rpm number and then ran appropriately until i turned it off.There was no patient injury.
Additional Manufacturer Narrative
There was no patient involvement.Livanova deutschland manufactures the centrifugal pump 5 (cp5).The incident occurred in (b)(4).A livanova field service representative was dispatched to the facility to investigate the device and could not reproduce the reported issue.The drive unit was replaced as precaution.Reportedly, a similar issue happened about 4 months before and the drive motor and the processor board in the cp5 console were replaced.If any additional information pertinent to the reported event is received, it will be provided in a supplemental report.
Additional Manufacturer Narrative
H.10: based on similar events investigations, the reported issue can be due to: defective processor board which is located in cp5 pump control panel; defective circuit board motor control board which is located in the drive unit; communication failure between processor board and motor control board.Considering that functional test performed by technician did not reproduce the issue and no problem was detected with the drive unit, a defective circuit board motor control can be excluded as potential root cause.Taking into account that no problem was detected with cp5 control panel, which was not replaced and is still in use in customer facility, defective processor board can be excluded as well as potential root cause.Therefore, the most likely root cause of the event can be traced back to intermittent serial communication failure between processor board and motor control board.
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: 15189829
• Report Number: 9611109-2022-00404
• Device Sequence Number: 6013440
• Product Code: DWA
• UDI-Device Identifier: 04033817900948
• UDI-Public: (01)04033817900948(11)210427
• 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): 08/09/2022

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: 60-01-04
• 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: 07/18/2022
• Supplement Date Received by Manufacturer: 09/20/2022
• Initial Report FDA Received Date: 08/09/2022
• Supplement Report FDA Received Date: 10/20/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/27/2021
• 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