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

Model Number 60-03-75

Device Problem No Display/Image (1183)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/25/2017

Event Type  malfunction  

Manufacturer Narrative

Patient information was not provided.Livanova (b)(4) manufactures the centrifugal pump console.The incident occurred in (b)(6).This medwatch report is being filed on behalf of livanova (b)(4).If any additional information pertinent to the reported event is received, it will be provided in a supplemental report.

Event Description

Livanova received a report that the screen of the centrifugal pump console went blank during a procedure.There was no report of patient injury.

Manufacturer Narrative

A livanova field service representative was dispatched to the facility to investigate.The service representative was unable to confirm the reported issue.The device worked according the specification.Subsequent functional verification testing was completed without issues and the unit was returned to service.A review of the dhr did not identify any deviations or non-conformities relevant to the reported issue.

Event Description

See initial report.

• Brand Name: CENTRIFUGAL PUMP CONSOLE
• Type of Device: PUMP, BLOOD, CARDIOPULMONARY BYPASS, NON-ROLLER TYPE
• Manufacturer (Section D): LIVANOVA DEUTSCHLAND; lindberghstr. 25; munich 80939 ; GM 80939
• Manufacturer (Section G): LIVANOVA DEUTSCHLAND; lindberghstr. 25; munich 80939 ; GM 80939
• Manufacturer Contact: joan ceasar ; 14401 w. 65th way; arvada, CO 80004 ; 2812287260
• MDR Report Key: 6874280
• MDR Text Key: 87336748
• Report Number: 9611109-2017-00729
• Device Sequence Number: 1
• Product Code: KFM
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K020571
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Biomedical Engineer
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 07/27/2018

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: 60-03-75
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 08/25/2017
• Initial Date FDA Received: 09/18/2017
• Supplement Dates Manufacturer Received: 07/02/2018
• Supplement Dates FDA Received: 07/27/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/24/2014
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1