MAUDE Adverse Event Report: LIVANOVA DEUTSCHLAND GMBH CENTRIFUGAL PUMP SYSTEM WITH TUBING CLAMP; CONTROL, PUMP SPEED, CARDIOPULMONARY BYPASS

Model Number 60-02-50

Device Problem Pumping Problem (3016)

Patient Problem No Patient Involvement (2645)

Event Date 08/29/2018

Event Type  malfunction  

Manufacturer Narrative

There was no patient involvement.Livanova deutschland manufactures the centrifugal pump system with tubing clamp.The incident occurred in (b)(6).A review of the dhr could not identify any deviations or nonconformities relevant to the issue.The scp panel was requested for further investigation.A visual inspection, a functional test and an hardware analysis were performed without detecting deviations: the unit worked as expected and within specification.No hardware failures were detected.Based on all the above facts, it cannot be ruled out that an intermittent connection between the motor control board and the hall sensor / pump control panel, contributed to the reported malfunction.It is likely that some mechanical change like temperature, vibration and / or physical stress of the panel led to the intermittent connections.

Event Description

Livanova received a report that an error code related to the drive unit of a centrifugal pump system with tubing clamp was displayed on the scp control panel during set-up.There was no patient involvement.

• Brand Name: CENTRIFUGAL PUMP SYSTEM WITH TUBING CLAMP
• 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: 9768521
• MDR Text Key: 191697055
• Report Number: 9611109-2020-00151
• Device Sequence Number: 1
• Product Code: DWA
• Combination Product (y/n): N
• Reporter Country Code: US
• 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: 02/28/2020

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: 60-02-50
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 08/29/2018
• Initial Date FDA Received: 02/28/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/16/2014
• 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