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

Model Number 28-95-80

Device Problems No Display/Image (1183); Pumping Stopped (1503)

Patient Problem Death (1802)

Event Date 11/29/2017

Event Type  Death  

Manufacturer Narrative

(b)(6).Livanova (b)(4) manufactures the s5 control panel mrp 150/85.The incident occurred in (b)(6).A livanova field service representative was dispatched to the facility to investigate.The service representative was unable to confirm the reported issue.Functional verification testing was completed without fault.A serial readout was performed and sent to livanova (b)(4) for further evaluation.Analysis of the readout was able to confirm that the device was hand cranked, however the reported display and pump stop malfunctions could not be confirmed.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.Device not returned.

Event Description

Livanova (b)(4) received a report that the display of an s5 control panel mrp went blank and the pump stopped working during a procedure.The user began to hand crank and was able to restart the pump successfully after several attempts.The procedure was completed without further issues.The patient died one day after the operation of multiple organ failure.It is unknown at this time if the patient death is related to the event.

Manufacturer Narrative

The mast roller pump system was returned to livanova (b)(4) for detailed investigation.During the investigation, no failures could be identified.The device worked according the specification and the reported issue was not reproduced.As the issue could not be reproduced, a root cause was not identified.

• 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 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: 7142648
• MDR Text Key: 95632236
• Report Number: 9611109-2017-01044
• Device Sequence Number: 1
• Product Code: DWB
• Combination Product (y/n): N
• Reporter Country Code: TW
• 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: 05/22/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/22/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 28-95-80
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/20/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/06/2014
• 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
• Patient Outcome(s): Death
• Patient Age: 48 YR
• Patient Weight: 100