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

Model Number 48-30-00

Device Problems Device Operational Issue (2914); Improper Alarm (2951)

Patient Problem No Patient Involvement (2645)

Event Date 05/17/2016

Event Type  malfunction  

Manufacturer Narrative

Sorin group (b)(4) manufactures the sorin s5 system.The incident occurred in (b)(6).This medwatch report is being filed on behalf of sorin group (b)(4) sorin group (b)(4) received a report that the level alarm for the sorin s5 system failed and caused an alarm during priming.There was no patient involvement.A sorin group field service representative was dispatched to the facility to investigate.The service representative was unable to reproduce the reported error on site.The dc/dc module was replaced as a precaution and subsequent testing revealed no further issues.The dc/dc module was returned to sorin group (b)(4) for further analysis.The investigation is ongoing.A follow-up report will be sent when the investigation is complete.

Event Description

Sorin group (b)(4) received a report that the level alarm for the sorin s5 system failed and caused an alarm during priming.There was no patient involvement.

Manufacturer Narrative

(b)(4) manufactures the s5 system.The incident occurred in (b)(6).This medwatch report is filed on behalf of (b)(4).(b)(4) requested that the dc/dc-module be returned for further investigation.The unit was received for inspection and analysis; according to inspector the reported issue could be reproduced, but no deviations could be found during the visual inspection, the functional testing and the hardware analysis.The inspector noted that it is very likely that there is a sporadic problem with one of the dc/dc-converters.The dc/dc-module was scrapped for safety reason.A review of the dhr did not identify any deviations or nonconformities relevant to the issue.As there is no trend for this kind of issue no corrective action is necessary; (b)(4) will continue to monitor the market for trends related to this type of issue.

• Brand Name: SORIN 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 80939 ; GM 80939
• Manufacturer Contact: joan ceasar ; 14401 w. 65th way; arvada, CO 80004 ; 2812287260
• MDR Report Key: 5718793
• MDR Text Key: 47209407
• Report Number: 9611109-2016-00359
• Device Sequence Number: 1
• Product Code: DTQ
• Combination Product (y/n): N
• Reporter Country Code: GM
• 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: 11/06/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/10/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 48-30-00
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/23/2016
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/18/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/15/2006
• 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