MAUDE Adverse Event Report: LIVANOVA DEUTSCHLAND CENTRIFUGAL PUMP CONSOLE; PUMP, BLOOD, CARDIOPULMONARY BYPASS, NON-ROLLER TYPE

Model Number 60-03-75

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem No Patient Involvement (2645)

Event Date 10/22/2018

Event Type  malfunction  

Manufacturer Narrative

There was no patient involvement.Livanova (b)(4) manufactures the centrifugal pump console.The incident occurred in (b)(6).The livanova field representative who performed the maintenance checked all the modules, reconnected all the cables, but the issue persisted.Livanova (b)(4) requested the entire unit back for a detailed investigation but it was not made available.No investigation could not be carried out and no root cause could be determined.A review of the dhr could not identify any deviations or nonconformities relevant to the issue.

Event Description

Livanova received a report that, during a battery test, the message "no com" was displayed.The issue occurred during maintenance.There was no patient involvement.

• Brand Name: CENTRIFUGAL PUMP CONSOLE
• Type of Device: PUMP, BLOOD, CARDIOPULMONARY BYPASS, NON-ROLLER TYPE
• Manufacturer (Section D): LIVANOVA DEUTSCHLAND; lindberghstr. 25; munich 89309 ; GM 89309
• Manufacturer (Section G): LIVANOVA DEUTSCHLAND; lindberghstr. 25; munich 89309 ; GM 89309
• Manufacturer Contact: barbara galasso ; 14401 w. 65th way; arvada, CO 80004
• MDR Report Key: 8748004
• MDR Text Key: 149810040
• Report Number: 9611109-2019-00503
• Device Sequence Number: 1
• Product Code: KFM
• Combination Product (y/n): N
• Reporter Country Code: IN
• PMA/PMN Number: K020571
• 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: 07/01/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/01/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 60-03-75
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 10/22/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/23/2014
• 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