MAUDE Adverse Event Report: SORIN GROUP DEUTSCHLAND SORIN S3 BUBBLE DETECTOR; MONITOR AND/OR CONTROL, LEVEL SENSING, CARDIOPULMONARY BYPASS

Model Number 23-07-50

Device Problems False Alarm (1013); Device Operational Issue (2914)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 01/19/2017

Event Type  malfunction  

Manufacturer Narrative

Patient information was not provided.Sorin group (b)(4) manufactures the sorin s3 bubble detector.The incident occurred in (b)(6).This medwatch report is being filed on behalf of sorin group (b)(4).A review of the dhr did not identify any deviations or non-conformities relevant to the reported issue.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 sorin s3 bubble detector alarmed randomly and the tubing size setting changed on its own during a procedure.There was no report of patient injury.

Manufacturer Narrative

Livanova (b)(4) manufactures the s3 bubble detector.The incident occurred in (b)(6).This medwatch report is being filed on behalf of livanova (b)(4).On january 24, 2017, a livanova field service representative was dispatched to the facility to investigate.The service representative was unable to reproduce the reported fault.The bubble sensor and bubble module were replaced as a precaution.The device was functionally tested without issue and was returned to service.These service results were inadvertently not included in the initial report, submitted february 13, 2017.If any additional information pertinent to the reported event is received, it will be submitted in a supplemental report.Evaluated on site by service rep.

Manufacturer Narrative

Livanova (b)(4) manufactures the s3 bubble detector.The incident occurred in (b)(6).This medwatch report is being filed on behalf of livanova (b)(4).The bubble sensor and module were returned to livanova (b)(4) for investigation.During evaluation, the reported issue was confirmed.The vga gain value of the bubble sensor was found to be outside of the acceptance range, resulting in the bubble sensor not being reliable in its reading (i.E falsely alarming).This is a known issue and a root cause investigation has already been closed, concluding that the risk of an unintended change is very low.As corrective action, livanova (b)(4) is planning to develop an entirely new sensor.

• Brand Name: SORIN S3 BUBBLE DETECTOR
• Type of Device: MONITOR AND/OR CONTROL, LEVEL SENSING, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): SORIN GROUP DEUTSCHLAND; lindberghstrasse 25; munich,
• 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: 6326095
• MDR Text Key: 67323115
• Report Number: 9611109-2017-00060
• Device Sequence Number: 1
• Product Code: KRL
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K955152
• 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,Followup
• Report Date: 09/12/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/13/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 23-07-50
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/18/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/20/2016
• 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