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

Model Number 60-01-04

Device Problem Pumping Problem (3016)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 10/20/2021

Event Type  malfunction  

Event Description

Livanova (b)(4) received a report that a centrifugal pump 5 (cp5) gave a motor control failure error message during setup.There was no patient involvement.

Manufacturer Narrative

There was no patient involvement.Livanova (b)(4) 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 confirm the reported issue.The drive unit was replaced with another.The affected device returned to livanova arvada facility.Vibration was noticed when increasing rpms.The reported issue could not be reproduced during functional test.If any additional information pertinent to the reported event is received, it will be provided in a supplemental report.

Manufacturer Narrative

Udi code has been added to the dedicated d.4 section.Manufacturing date of device has been corrected in the dedicated h.4 section.H.10: the involved unit was manufactured in 2018 and according to the complaints database no similar events have been reported before.Based on similar events investigations, motor control failure can be due to: defective processor board of pump control panel; defective motor control board of the drive unit; intermittent communication failure between processor board and motor control board considering that functional test performed in arvada did not reproduce the issue and no problem was detected with the complained drive unit, it is unlikely that a defective motor control had caused the reported issue.In addition, taking into account that no problem was detected with cp5 control panel, which was not replaced and is still in use in customer facility, it is unlikely that a defective processor had caused the reported issue as well.Therefore, the most likely root cause of the event is an intermittent communication failure between processor board and motor control board.

Event Description

See initial report.

• Brand Name: CENTRIFUGAL PUMP 5 (CP5)
• Type of Device: 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: 13091960
• MDR Text Key: 285387764
• Report Number: 9611109-2021-00743
• Device Sequence Number: 1
• Product Code: DWA
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K112225
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Other Health Care Professional
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 12/28/2021

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
• Device Operator: Health Professional
• Device Model Number: 60-01-04
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 10/20/2021
• Initial Date FDA Received: 12/28/2021
• Supplement Dates Manufacturer Received: 03/10/2022
• Supplement Dates FDA Received: 04/07/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/07/2018
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1