MAUDE Adverse Event Report: LIVANOVA DEUTSCHLAND S3 LOW LEVEL II SENSOR; MONITOR AND/OR CONTROL, LEVEL SENSING, CARDIOPULMONARY BYPASS

Model Number 23-27-40

Device Problem Failure to Sense (1559)

Patient Problem No Patient Involvement (2645)

Event Date 01/23/2017

Event Type  malfunction  

Manufacturer Narrative

(b)(4) manufactures the s3 low level ii sensor.The incident occurred in (b)(6).This medwatch report is being filed on behalf of (b)(4).The (b)(4) field service representative on site for the routine service replaced the faulty level sensor to resolve the issue.Subsequent testing did not identify further issues.The replaced level sensor will be returned to sorin group usa for further investigation.A follow-up report will be sent when the investigation is complete.

Event Description

(b)(4) received a report that the s3 low level ii sensor failed to recognize the presence of liquid in the reservoir during maintenance.This issue was noted by a (b)(4) field service representative during routine service.There was no patient involvement.

• Brand Name: S3 LOW LEVEL II SENSOR
• Type of Device: MONITOR AND/OR CONTROL, LEVEL SENSING, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): LIVANOVA DEUTSCHLAND; lindberghstrasse 25; munich, 80939 ; GM 80939
• Manufacturer (Section G): LIVANOVA DEUTSCHLAND; lindberghstrasse 25; munich, 80939 ; GM 80939
• Manufacturer Contact: joan ceasar ; 14401 w. 65th way; arvada, CO 80004 ; 2812287260
• MDR Report Key: 6343780
• MDR Text Key: 67933570
• Report Number: 9611109-2017-00070
• Device Sequence Number: 1
• Product Code: DTW
• 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: company representative
• Reporter Occupation: Other
• Remedial Action: Other
• Type of Report: Initial
• Report Date: 02/20/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/20/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: 23-27-40
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 01/23/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/16/2009
• 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