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

Model Number 60-02-60

Device Problem Pumping Stopped (1503)

Patient Problems Death (1802); No Information (3190)

Event Type  Death  

Manufacturer Narrative

Patient information was not provided.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 and replaced the device with another one.He noticed that the customer uses an adapter not manufactured by livanova.The serial readout has been analyzed and results revealed that the issue was probably due to emc interferences.However, investigation is still in progress since this cannot be confirmed on the basis of the currently available information.Moreover, ss per the s5 system instruction for use, hlm device is not released for ecmo and the cp5 drive unit is not released for usage of adapter plates or other 3rd party accessories.A review of the dhr did not identify any deviations or non-conformities relevant to 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 a centrifugal pump 5 (cp5) displayed an internal malfunction error message and stopped more than once during ecmo procedure.Reportedly the patient is involved and no further details are known.

Event Description

See initial report.

Manufacturer Narrative

H.10: through follow-up communication livanova learned that the patient died.Reportedly, there is no relationship between the equipment and the patient outcome was identified.A review of the dhr did not identify any deviation or non conformities relevant for this issue as well as a service history review.The affected device were requested back to the manufacturer site for investigation.No deviations occurred during functional tests and the reported issue could not be reproduced.During the internal inspection it was found that the cooling fan was not spinning due to mechanical damage.Based on the read out analysis a watchdog error was stored in the date of the event and multiple warning messages related to a low fan speed were also stored on different dates.Based on the above, the most likely root cause of the reported malfunction is an overheating of the components caused by a defective cooling fan.The prolonged usage of the device for ecmo procedure may have contributed to the overheating of the circuit boards.

• Brand Name: CENTRIFUGAL PUMP 5 (CP5)
• Type of Device: CONTROL, PUMP SPEED, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): LIVANOVA DEUTSCHLAND GMBH; lindberghstr. 25; munich
• MDR Report Key: 9856370
• MDR Text Key: 194020687
• Report Number: 9611109-2020-00203
• Device Sequence Number: 1
• Product Code: DWA
• Combination Product (y/n): N
• PMA/PMN Number: K112225
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 03/19/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/19/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 60-02-60
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/30/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1