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

Model Number 48-50-00

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Air Embolism (1697)

Event Type  Injury  

Manufacturer Narrative

Patient information was not provided.Livanova (b)(4) manufactures the s5 system.The incident occurred in (b)(6).A livanova field service representative was dispatched to the facility to investigate the machine and could not identify any issues with the device.The pumps were checked and found to be working within specifications.The bubble sensor was checked and found to have slight dimpling in the bladder.However, it was found to be working properly and within specifications.In the extreme condition, a deflated bladder may result in oversensing of the bubble detector which will detect air bubbles even if no air bubble is present in the line.Subsequent functional verification testing was completed without further issues and the unit was returned to service.Livanova attempted to retrieve additional information about patient conditions and additional details about issues experienced during the procedure but no answer was provided.The biomedical engineer of the hospital communicated to livanova representative that likely the customer will not give any information about the event or the outcome.If any additional information pertinent to the reported event is received, it will be provided in a supplemental report.

Event Description

Livanova received report of an adverse outcome.Issue with air, air lock and low flow during a procedure were reported by the biomedical engineer of the hospital and a s5 system was used.The outcome of patient has not been communicated to the biomedical engineer of the hospital or to any livanova representative.No additional information were provided.A patient impact cannot be excluded.

Manufacturer Narrative

H.10: a review all of the dhr could not identify any deviations or non-conformities relevant to the issue.Based on the intensive tests performed on site by the livanova field service technician, hardware/software malfunctions with the s5 console can be ruled out as cause of the reported event and it is unlikely that the reported event was device related.

Event Description

See initial report.

• Brand Name: S5 SYSTEM
• Type of Device: CONSOLE, HEART-LUNG MACHINE, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): LIVANOVA DEUTSCHLAND; lindberghstrasse 25; munich
• Manufacturer (Section G): LIVANOVA DEUTSCHLAND; lindberghstrasse 25; munich 80309 ; GM 80309
• Manufacturer Contact: enrico greco ; 14401 w. 65th way; arvada, CO 80004
• MDR Report Key: 12877659
• MDR Text Key: 281283434
• Report Number: 9611109-2021-00676
• Device Sequence Number: 1
• Product Code: DTQ
• 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: Other Health Care Professional
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 11/26/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 48-50-00
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 10/28/2021
• Initial Date FDA Received: 11/26/2021
• Supplement Dates Manufacturer Received: 02/15/2022
• Supplement Dates FDA Received: 03/11/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/06/2013
• 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): Other