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

Model Number 60-02-60

Device Problem Decreased Pump Speed (1500)

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

Event Date 01/11/2022

Event Type  malfunction  

Event Description

Livanova (b)(4) received a report that during bypass, a level alarm correctly stopped the centrifugal pump 5 (cp5) and following to that the cp5 screen froze and the arterial clamp remained closed.Reportedly, it was not possible to press anything on the screen and it seemed there was also no response from the speed control knob.The pump was turned off and back on and bypass could be resumed.There was no report of patient injury.

Manufacturer Narrative

There was no patient involvement.Livanova (b)(4) manufactures the centrifugal pump 5 (cp5).The incident occurred in (b)(6).Through follow-up communication livanova learned that the screen froze during the alarm condition when the clamp was closed.The user was unable to see the flow rate or change the pump speed.The lines were manually clamped as the screen/clamp were not responding.The cp5 control panel was turned off and back on and the electrical clamp was manually opened.When power was restored, the cp5 control panel was replaced with another and procedure could be carried on with no further issues.A livanova field service representative was dispatched to the facility to investigate the device and could not reproduce the reported issue.If any additional information pertinent to the reported event is received, it will be provided in a supplemental report.

Manufacturer Narrative

There was no patient involvement.Livanova (b)(4) manufactures the centrifugal pump 5 (cp5).The incident occurred in (b)(6).Through follow-up communication livanova learned that the screen froze during the alarm condition when the clamp was closed.The user was unable to see the flow rate or change the pump speed.The lines were manually clamped as the screen/clamp were not responding.The cp5 control panel was turned off and back on and the electrical clamp was manually opened.When power was restored, the cp5 control panel was replaced with another and procedure could be carried on with no further issues.A livanova field service representative was dispatched to the facility to investigate the device and could not reproduce the reported issue.If any additional information pertinent to the reported event is received, it will be provided in a supplemental report.

Event Description

Livanova (b)(4) received a report that during bypass, a level alarm correctly stopped the centrifugal pump 5 (cp5) and following to that the cp5 screen froze and the arterial clamp remained closed.Reportedly, it was not possible to press anything on the screen and it seemed there was also no response from the speed control knob.The pump was turned off and back on and bypass could be resumed.There was no report of patient injury.

Manufacturer Narrative

H10: through follow-up communication livanova learned that the intention was to resolve the alarm, open the clamp and resume flow.The level in the reservoir was resolved via the system panel.The main problem was that the touch screen did not respond to any touch.The menu couldn¿t be entered into, the clamp could not be opened despite resolving the level alarm on the system panel.If any additional information pertinent to the reported event is received, it will be provided in a supplemental report.

Event Description

See initial report.

Manufacturer Narrative

H.10: the affected device was returned to the manufacturer site for repair.The reported issue could not be reproduced upon device testing.However, the processor board, the touchscreen and the ribbon cables will be replaced.Repair is pending customer approval.If any additional information pertinent to the reported event is received, it will be provided in a supplemental report.

Event Description

See initial report.

Manufacturer Narrative

H10: the customer approved the repair quotation.The device was re-tested before repair and the issue could be reproduced.The processor board, the touchscreen and the ribbon cables have been replaced.Subsequent functional verification testing was completed without further issues and the unit was returned to service.The most likely root cause of the reported issue could be traced back to an intermittent malfunction of the processor 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: 13477693
• MDR Text Key: 285691493
• Report Number: 9611109-2022-00055
• Device Sequence Number: 1
• Product Code: DWA
• UDI-Device Identifier: 04033817901006
• UDI-Public: (01)04033817901006(11)181207
• Combination Product (y/n): N
• Reporter Country Code: UK
• 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,Followup,Followup
• Report Date: 02/07/2022

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
• Device Operator: Health Professional
• Device Model Number: 60-02-60
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 01/11/2022
• Initial Date FDA Received: 02/08/2022
• Supplement Dates Manufacturer Received: 02/16/2022; 03/23/2022; 08/03/2022
• Supplement Dates FDA Received: 03/17/2022; 04/20/2022; 09/01/2022
• 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