MAUDE Adverse Event Report: SORIN GROUP DEUTSCHLAND S5 SENSOR MODULE FOR BUBBLE DETECTION; CONSOLE, HEART-LUNG MACHINE, CARDIOPULMONARY BYPASS

Model Number 23-45-20

Device Problem Failure to Auto Stop (2938)

Patient Problem No Patient Involvement (2645)

Event Date 06/27/2016

Event Type  malfunction  

Manufacturer Narrative

There was no patient involvement.Sorin group (b)(4) manufactures the s5 sensor module for bubble detection.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 s5 sensor module for bubble detection did not consistently activiate and shut off the pump.This issue was discovered by a sorin group field service representative during maintenance, so there was no patient involvement.The service representative tried clearing the nvmem, but the issue was not resolved.The sensor module was replaced.The unit was tested with the new module and was found to be working correctly.No further issues were observed and the unit was returned to service.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 s5 sensor module for bubble detection did not consistently activiate and shut off the pump.This issue was discovered by a sorin group field service representative during maintenance, so there was no patient involvement.

Manufacturer Narrative

Livanova (b)(4) manufactures the s5 sensor module for bubble detection.The incident occurred in (b)(6).This medwatch report is being filed on behalf of sorin group (b)(4).The device was returned to sorin group usa, inc.For evaluation.Visual inspection did not identify any abnormalities or defects and functional testing was unable to reproduce the reported issue.The device was cold-started three times and run for 30 minutes without error.As the issue could not be reproduced, a root cause was not determined and corrective actions were not identified.A review of the dhr did not identify any deviations or non-conformities relevant to the reported issue.Evaluated at sorin group usa, inc.

• Brand Name: S5 SENSOR MODULE FOR BUBBLE DETECTION
• Type of Device: CONSOLE, HEART-LUNG MACHINE, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): SORIN GROUP 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: 5817525
• MDR Text Key: 50306226
• Report Number: 9611109-2016-00458
• Device Sequence Number: 1
• Product Code: DTW
• 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: Health Professional
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 03/21/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/22/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 23-45-20
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/23/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/03/2012
• 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