MAUDE Adverse Event Report: LIVANOVA DEUTSCHLAND SENSOR MODULE FOR BUBBLE DETECTOR; CONSOLE, HEART-LUNG MACHINE, CARDIOPULMONARY BYPASS

Model Number	23-45-20
Medical Device Problem Code	False Alarm (1013)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	04/13/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Livanova (b)(4) manufactures the sensor module for bubble detector.The incident occurred in (b)(6).The defective sensor was requested for further investigation.A review of the dhr could not identify any deviations or nonconformities relevant to the issue.If any additional information pertinent to the reported event is received, it will be provided in a supplemental report.
Event or Problem Description
Livanova (b)(4) received a report that a sensor module for bubble detector is giving false alarm.There was no report of patient injury.
Additional Manufacturer Narrative
A livanova field service representative was dispatched to the facility to investigate.The service representative was able to confirm the reported issue and traced the failure to the bubble sensor and bubble sensor module.Both components were replaced and subsequent functional verification testing was completed without further issues.The unit was returned back to service.The replaced devices were returned to livanova usa, where visual inspection was performed.Inspection was unable to identify any abnormalities, defects or physical damage to the device.The bubble module and sensor were returned to livanova (b)(4) for further investigation.During the investigation, the reported issue could not be confirmed.Both devices were extensively tested under various conditions without failure.The devices worked according the specifications.As the issue could not be reproduced during in-depth testing, a root cause could not be identified.This mdr has been already submitted july 06, 2018 and resubmitted due to missing 3rd acknowledgment.

• Brand Name: SENSOR MODULE FOR BUBBLE DETECTOR
• Common Device Name: CONSOLE, HEART-LUNG MACHINE, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): LIVANOVA DEUTSCHLAND; lindberghstr. 25; munich 80939 ; GM 80939
• MDR Report Key: 7510335
• Report Number: 9611109-2018-00957
• Device Sequence Number: 1383344
• Product Code: DXC
• UDI-Device Identifier: 04033817900665
• UDI-Public: 010403381790066511180123
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K071318
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Health Professional
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 07/06/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 23-45-20
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 04/13/2018
• Supplement Date Received by Manufacturer: 06/15/2018
• Initial Report FDA Received Date: 05/14/2018
• Supplement Report FDA Received Date: 07/16/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1