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

Model Number 60-02-60

Device Problem Pumping Stopped (1503)

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

Event Date 11/22/2021

Event Type  malfunction  

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 rumpdown function was activated for pressure monitoring indicating that in case of pressure alarm the cp5 automatically decreases the rpms.In addition it was learned that rpms and flow showed on the display of the control panel were not zero while the pump was reported to be stopped indicating that the control panel was freezed.Investigation is ongoing.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 the message ¿no monitoring on pump 2b¿ (cardioplegia pump) referring to the stop link function appeared on a centrifugal pump 5 (cp5) ¿during priming when the perfusionist was away from the pump.Reportedly, the pressure reading was negative with associated alarm and the centrifugal pump stopped.The cp5 screen was still saying the same and when it was attempted to press the clamp function button to close the clamp it appeared to be frozen.The pump was power cycled and it worked normally again.However, since cpb had not yet been initiated, the user replaced the cp5 with another under livanova technical service advice.There was no patient involvement.

Event Description

See initial report.

Manufacturer Narrative

H.10: the error message "no monitoring on pump 2b", related to the cardioplegia pump, is displayed when the link (stop-link function) between the arterial pump (in this case the centrifugal pump) and the cardioplegia pump is interrupted.This link can be interrupted if: - the cp5 control panel is switched off by the user; - the cp5 control panel turns off because of a malfunction.The serial read-out of the cp5 control panel (real time device parameters and setting recording file) was gathered and analyzed, confirming that during the day of the event the cp5 control panel turned off by itself (stopping the centrifugal pump consequently).The stop of the centrifugal pump led to the pressure negative alarm and consequently to the closure of the erc clamp, which, during the alarm situation, could no longer be operated by the user.Therefore, the pressure alarm as well as the inoperability of the erc clamp are both expected behaviors of the devices.The cp5 control panel was requested and a dedicated investigation was performed.During the intensive test carried out no malfunctions of the cp5 control panel was observed and the unit worked within specifications.Based on all the above facts, it cannot be ruled out that an intermittent issue of the computer board of the cp5 control panel could have led to the reported event.

Event Description

See initial report.

Manufacturer Narrative

H.10: the device was returned to the manufacturer site for repair and additional tests were performed and no issues could be found confirming that the most likely root cause of the reported issue could have been an intermittent issue of the computer board of the cp5 control panel.Subsequent functional verification testing was completed without further issues and the unit was returned to service.

• 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: 13060866
• MDR Text Key: 285359622
• Report Number: 9611109-2021-00716
• Device Sequence Number: 1
• Product Code: DWA
• UDI-Device Identifier: 04033817901006
• UDI-Public: 010403381790100611160419
• 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
• Report Date: 12/22/2021

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: 60-02-60
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 11/22/2021
• Initial Date FDA Received: 12/22/2021
• Supplement Dates Manufacturer Received: 05/06/2022; 06/17/2022
• Supplement Dates FDA Received: 06/03/2022; 07/15/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/19/2016
• 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