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

Model Number 28-95-85

Device Problems Loss of Power (1475); No Flow (2991)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/11/2017

Event Type  malfunction  

Manufacturer Narrative

Patient information was not provided.Livanova (b)(4) manufactures the s5 control panel mrp.The event occurred in (b)(6).This medwatch report is being filed on behalf of livanova (b)(4).The device was returned to livanova (b)(4) for investigation.During the evaluation, the reported issue was not reproduced.However, a serial readout was performed and the reported issue was confirmed and was found to be caused by firmware bugs in the micro-controller.The bugs can be caused if the device is updated without clearing the nvmem.The nvmem was erased and the reported deviation did not appear again.The device was tested extensively at various speeds and configurations over 2 hours with no defects noted.A review of the dhr did not identify any deviations or non-conformities relevant to the reported issue.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 an s5 control panel mrp lost power and rebooted during a procedure.The flow went to zero and had to be reset to 900 by the user.The customer reported that this is the second time this has happened.There was no report of patient injury.

Manufacturer Narrative

In the initial report, submitted (b)(6) 2017, the date returned to manufacturer was inadvertently left blank.The date of return is (b)(6) 2017.

• Brand Name: S5 CONTROL PANEL MRP
• Type of Device: CONSOLE, HEART-LUNG MACHINE, CARDIOPULMONARY BYPASS
• 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: 7004943
• MDR Text Key: 92201095
• Report Number: 9611109-2017-00896
• Device Sequence Number: 1
• Product Code: DWB
• Combination Product (y/n): N
• Reporter Country Code: JA
• 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
• Report Date: 11/07/2017

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: 28-95-85
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/27/2017
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/13/2017
• Initial Date FDA Received: 11/06/2017
• Supplement Dates Manufacturer Received: 10/13/2017
• Supplement Dates FDA Received: 11/07/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/24/2011
• 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