MAUDE Adverse Event Report: LIVANOVA DEUTSCHLAND S5 CONTROL PANEL MRP 150/85; CONSOLE, HEART-LUNG MACHINE, CARDIOPULMONARY BYPASS

Model Number 28-95-80

Device Problem Device Operational Issue (2914)

Patient Problem No Patient Involvement (2645)

Event Date 06/21/2017

Event Type  malfunction  

Manufacturer Narrative

There was no patient involvement.The serial number has not been provided.This information will be provided in a supplemental report if made available.As the serial number is unknown, the device manufacture date could not be determined.This information will be provided in a supplemental report if made available.Livanova (b)(4) manufactures the s5 control panel mrp.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 (b)(4) received a report that a encoder of a s5 control panel mrp was found to be loose during priming.There was no patient involvement.

Manufacturer Narrative

Serial number: (b)(4).Device manufacture date: november 3, 2014.A review of the dhr did not identify any deviations or non-conformities relevant to the reported issue.

Manufacturer Narrative

A livanova service representative was dispatched to the facility to investigate the issue.The technician could reproduce the issue as it was evident by the difficulty in rotating the knob.The service representative had opened the complete panel and dismantled the circuits and re-assembled the same and fastened the knob.Subsequent functional verification testing was completed without further issues and the unit was returned to service.A specific root cause for the reported issue could not be identified.Probable causes for the reported issue could be improper user technique and mishandling.

• Brand Name: S5 CONTROL PANEL MRP 150/85
• Type of Device: CONSOLE, HEART-LUNG MACHINE, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): LIVANOVA DEUTSCHLAND; lindberghstr. 25; munich
• Manufacturer (Section G): LIVANOVA USA; lindberghstr. 25; munich 80939 ; GM 80939
• Manufacturer Contact: joan ceasar ; 14401 w. 65th way; arvada, CO 80004 ; 2812287260
• MDR Report Key: 6715416
• MDR Text Key: 80144841
• Report Number: 9611109-2017-00534
• Device Sequence Number: 1
• Product Code: DWB
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K071318
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Health Professional
• Remedial Action: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 12/07/2017

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: 28-95-80
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/21/2017
• Initial Date FDA Received: 07/14/2017
• Supplement Dates Manufacturer Received: 07/24/2017; 11/24/2017
• Supplement Dates FDA Received: 08/17/2017; 12/11/2017
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 11/03/2014
• 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