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

Model Number 48-40-00

Device Problem Failure to Sense (1559)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 07/03/2019

Event Type  malfunction  

Manufacturer Narrative

There was no patient involvement.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 product.Through follow-up communication with the service technician in charge, livanova (b)(4) learned the he tested the system and was not able to reproduce the 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 a s5 system flow sensor was not measuring blood flow during procedure.There was no report of patient injury.

Manufacturer Narrative

H.10: no hardware failures have been detected with the claimed unit.A flow rate not displayed could be caused by a defective flow sensor, by a defective flow board of the control panel or to a tubing size not compatible with the flow probe in use.Therefore, it is likely that an incorrect tubing size was in use when the issue was detected.A review of the dhr could not identify any deviations or nonconformities relevant to the issue.

Event Description

See initial report.

• Brand Name: S5 SYSTEM
• Type of Device: CONSOLE, HEART-LUNG MACHINE, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): LIVANOVA DEUTSCHLAND; lindberghstr. 25; munich
• MDR Report Key: 8855014
• MDR Text Key: 175221004
• Report Number: 9611109-2019-00586
• Device Sequence Number: 1
• Product Code: DTQ
• UDI-Device Identifier: 04033817900894
• UDI-Public: 010403381790089411170921
• Combination Product (y/n): N
• PMA/PMN Number: K071318
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 01/14/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/02/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 48-40-00
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 12/16/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1