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

Model Number 48-40-00

Device Problems Increase in Pressure (1491); Pumping Stopped (1503)

Patient Problem Death (1802)

Event Date 02/17/2017

Event Type  Death  

Manufacturer Narrative

Patient identifier was not provided.Patient weight was not provided.(b)(4).A livanova field service representative was dispatched to the facility to investigate.The service representative did not identify any issues with the device.A serial readout was performed and will be provided to livanova (b)(4) for investigation.The service representative believes the device is back in use.A review of the dhr did not identify any deviations or non-conformities relevant to the reported issue.The investigation is on-going.If any additional information pertinent to the reported event is received, it will be provided in a supplemental report.Unit availability unk.; eval'd on site.

Event Description

Livanova (b)(4) received a report that the pressure of the oxygenator attached to the s5 system rapidly increased approximately 10 minutes after initiating an emergency surgery of aorta dissection following cardiac arrest of the patient.The pressure increase lead to a pump stop.The patient was taken off bypass and the heart stopped a few minutes later.The patient expired.

Manufacturer Narrative

Livanova (b)(4) manufactures the s5 system.The incident occurred in (b)(6).(b)(4).During the serial read out analysis performed at livanova (b)(4), several pressure alarms were detected as well as an arterial pump stop, which was caused by one pressure alarm.The readout showed that the user opened the cover of the arterial pump and started hand cranking.After the patient was declared dead, the alarm was cleared and after this action the pump began to run again without further issues.Based on the readout of the device, the pump and the pressure sensor module functioned as intended and the s5 system worked according to specification.No device malfunction was identified.Livanova (b)(4) analyzed data log.

• Brand Name: S5 SYSTEM
• Type of Device: CONSOLE, HEART-LUNG MACHINE, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): LIVANOVA DEUTSCHLAND; lindberghstr. 25; munich,
• 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: 6443127
• MDR Text Key: 71156206
• Report Number: 9611109-2017-00247
• Device Sequence Number: 1
• Product Code: DTQ
• Combination Product (y/n): N
• Reporter Country Code: SW
• PMA/PMN Number: K071318
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Other
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 08/10/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/29/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 48-40-00
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 07/17/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/26/2009
• 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: 52 YR