MAUDE Adverse Event Report: LIVANOVA DEUTSCHLAND S5 BUBBLE DETECTOR; MONITOR AND/OR CONTROL, LEVEL SENSING, CARDIOPULMONARY BYPASS

Model Number 23-07-50

Device Problems Pumping Stopped (1503); Device Displays Incorrect Message (2591)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 07/15/2017

Event Type  malfunction  

Manufacturer Narrative

Patient information was not provided.(b)(4) manufactures the s5 bubble detector.The incident occurred in (b)(6).This medwatch report is being filed on behalf of livanova (b)(4).A livanova field service representative was dispatched to the facility to investigate.The service representative was unable to reproduce the reported issue.The bubble detection system was tested with the pump of the s5 system for more than 4 hours and the device functioned as expected without any alarm.The module software was flashed and no issues were noted.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.Device not returned.

Event Description

Livanova (b)(4) received a report that the s5 system displayed an error message that the s5 bubble detector and the bubble detection system were defective during a procedure.The s5 system alarmed and the pump controlled by the bubbles detection system stopped immediately.The perfusionist attempted to override the alarm several times but was unable to do so and the case was completed without the bubble detection system.There was no report of patient injury.

Manufacturer Narrative

Livanova (b)(4) manufactures the s5 bubble detector.The incident occurred in (b)(6).This medwatch report is being filed on behalf of livanova (b)(4).The bubble sensor and the bubble sensor module were returned to livanova (b)(4) for further investigation.During evaluation, the reported issue was confirmed.The sensor module tested without issue, but the bubble sensor was found to have deflated sensor cushions, which caused the reported issue.For safety reasons the, bubble sensor is to be scrapped.Corrective actions are in progress for this type of issue.

• Brand Name: S5 BUBBLE DETECTOR
• Type of Device: MONITOR AND/OR CONTROL, LEVEL SENSING, 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: 6779150
• MDR Text Key: 82781430
• Report Number: 9611109-2017-00623
• Device Sequence Number: 1
• Product Code: KRL
• Combination Product (y/n): N
• 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
• Report Date: 09/26/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/09/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 23-07-50
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/01/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/19/2015
• 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