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

Model Number 60-02-60

Device Problem Insufficient Flow or Under Infusion (2182)

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

Event Date 06/08/2023

Event Type  malfunction  

Manufacturer Narrative

A.1.-a.5.There was no patient involvement.H10: livanova deutschland manufactures the centrifugal pump 5 (cp5).The incident occurred in morgantown, west virginia.Through follow-up communication livanova learned the following information: - the unit was not accidentally powered off by the user; - even if the control panel screen went black, the pump kept running; - when support was resumed, flow was adequate to separate the patient from bypass while the operator got another hlm machine and swapped; - the pump made some noises and it could not possible to reach a flow more than 1l per minutes; - also it was not possibile to activate electrical remote-controlled (erc) clamp from the cp5 console after cycling the power.- no issue occurred with the other pumps in use.Customer's biomedical engineer checked the involved cp5 and no deviation was found.Moreover, it was confirmed by the customer that the unit has been used then clinically with no issues.If any additional information pertinent to the reported event is received, it will be provided in a supplemental report.

Event Description

Livanova deutschland received a report that control panel screen of a centrifugal pump 5 (cp5) went black upon initiation of surgery.The unit power was turned off and back on and when support was resumed adequate flow was not able to be achieved.There was no patient injury.

Manufacturer Narrative

H10: complaints database analysis revealed that no similar event on this device occurred since its installation in 2017.According to the information reported, it is reasonable to assume that the complained case was a non-systematic event.In addition, considering the nature of all the problems experienced by the customer during the procedure and taking into account that no deviation was identified when the system was checked, it cannot be ruled out that the most likely contributing factor to the event are: a temporary/intermittent failure, probably of the computer board (hkr) or the motor control board.An electrical interference caused by an outside source.

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 80939 ; GM 80939
• Manufacturer Contact: enrico greco ; 14401 w. 65th way; arvada, CO 80004
• MDR Report Key: 17276743
• MDR Text Key: 318558377
• Report Number: 9611109-2023-00308
• 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: 07/06/2023

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: 06/08/2023
• Initial Date FDA Received: 07/07/2023
• Supplement Dates Manufacturer Received: 08/31/2023
• Supplement Dates FDA Received: 09/29/2023
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 02/13/2017
• 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