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

Model Number 48-40-00

Device Problem Device Displays Incorrect Message (2591)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/04/2018

Event Type  malfunction  

Manufacturer Narrative

Patient information was not provided.Livanova (b)(4) manufactures the s5 system.The event occurred in (b)(6).A livanova field service representative was dispatched to the facility to investigate.The service representative confirmed the reported issue and returned the dc/dc module to livanova (b)(4) for further investigation.Evaluation of the returned dc/dc module confirmed the reported issue.After several minutes of testing, the output voltage of the module was no longer present.A new dc/dc module was installed on the hdc board and subsequent testing did not identify further issues.The replaced module was dispositioned as scrap.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 system displayed a power supply sensor error during a procedure.There was no report of patient injury.

• Brand Name: S5 SYSTEM
• 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 80039 ; GM 80039
• Manufacturer Contact: joan ceasar ; 14401 w. 65th way; arvada, CO 80004 ; 2812287260
• MDR Report Key: 7555285
• MDR Text Key: 109753097
• Report Number: 9611109-2018-01010
• Device Sequence Number: 1
• Product Code: DTQ
• Combination Product (y/n): N
• Reporter Country Code: IT
• 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
• Report Date: 05/30/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/30/2018
• 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 Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/16/2018
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/05/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/30/2006
• 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