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

Model Number 60-02-60

Device Problem Pumping Problem (3016)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 02/14/2020

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).A livanova field service representative was dispatched to the facility to investigate and was informed that the same issue occurred in the past.The affected device was requested for a detailed investigation at the manufacturer site.The pump serial read-out analysis revealed six "watch-dog" events which imply an automatic reset of the pump and thus the reported black screen.However, the affected pump was tested and the issue could not be reproduced during the investigation.Based on the investigation results and on the feedback provided to the service engineer by the customer, it cannot be ruled out that the multiple pump reboots had been caused by interferences in the operating theatre.

Event Description

Livanova (b)(4) received a report that a centrifugal pump 5 (cp5) suddenly stopped during procedure six (6) times for about five (5) seconds and the display became black.Error messages popped up on the control panel display.The device was removed from service.There was no report of patient injury.

• Brand Name: CENTRIFUGAL PUMP 5 (CP5)
• Type of Device: CONTROL, PUMP SPEED, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): LIVANOVA DEUTSCHLAND GMBH; lindberghstr. 25; munich 80309 ; GM 80309
• Manufacturer (Section G): LIVANOVA DEUTSCHLAND GMBH; lindberghstr. 25; munich 80309 ; GM 80309
• Manufacturer Contact: enrico greco ; 14401 w. 65th way; arvada, CO 80004
• MDR Report Key: 9842863
• MDR Text Key: 197144112
• Report Number: 9611109-2020-00193
• Device Sequence Number: 1
• Product Code: DWA
• Combination Product (y/n): N
• Reporter Country Code: EN
• 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
• Report Date: 03/16/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/17/2020
• 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
• Date Manufacturer Received: 02/16/2020
• Date Device Manufactured: 04/18/2018
• 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