MAUDE Adverse Event Report: LIVANOVA DEUTSCHLAND GMBH ACCESSORIES; CONSOLE, HEART-LUNG MACHINE, CARDIOPULMONARY BYPASS

Model Number	BUBBLE SENSOR 1/4¿ X 1/16¿ (MODEL NUMBER 96-414-330)
Medical Device Problem Code	Low Readings (2460)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/29/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A.1.-a.5.Patient information were not provided.H10: livanova deutschland manufactures the bubble sensor.The incident occurred in ireland.If any additional information pertinent to the reported event is received, it will be provided in a supplemental report.
Event or Problem Description
Livanova deutschland received a report that a bubble sensor detector did not detect air bubbles; it stopped to alarm.The issue occurred at setup.Restart of the unit cleared the issue.There was no patient involvement.
Additional Manufacturer Narrative
A video of the issue was provided thus confirming the reported condition.From the analysis of the video, it can be highlighted that the bubble sensor was correctly enabled on the essenz cockpit then the perfusionist introduced air into the circuit through a syringe but no alarm was triggered by the sensor.The claimed bubble sensor was returned to the supplier for a dedicated investigation.The supplier repeated the end of line (eol) test, and as a part of the eol the bubble test was performed.The bubble test aims to verify the capacity of the sensor to detect air in the tube through a specific probe that simulates bubbles of different sizes.For 1/4 x 1/16 bubble sensor case a 3mm probe is used to simulate bubbles with a diameter of 3.0 mm.The sensor passed all the tests and no deviation was detected.Complaints database review was performed and revealed that no further similar issue was submitted against the essenz hlm involved in this complaint.Moreover, statistical data analysis, performed hasn't identified any concerning trend for this specific issue.Based on the above facts, the root cause of the reported event is unknown.The risk is in the acceptable region.No specific action was currently deemed necessary.Livanova will keep monitoring the market.
Event or Problem Description
See initial report.
Additional Manufacturer Narrative
Udi related data quality updates only: d1.Brand name has been corrected and updated in the dedicated section.D4.Model number has been corrected and updated in the dedicated section.

• Brand Name: ACCESSORIES
• Common Device Name: CONSOLE, HEART-LUNG MACHINE, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): LIVANOVA DEUTSCHLAND GMBH; lindberghstrasse 25; munich
• Manufacturer (Section G): LIVANOVA DEUTSCHLAND GMBH; lindberghstrasse 25; munich 80939 ; GM 80939
• Manufacturer Contact: enrico greco ; 14401 w. 65th way; arvada, CO 80004
• MDR Report Key: 18407710
• Report Number: 9611109-2023-00660
• Device Sequence Number: 8723957
• Product Code: DTQ
• UDI-Device Identifier: 04033817902430
• UDI-Public: (01)04033817902430(11)221103
• Combination Product (Y/N): N
• Initial Reporter Country: EI
• PMA/510(K) Number: K232291
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other
• Remedial Action: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 08/16/2024

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: BUBBLE SENSOR 1/4¿ X 1/16¿ (MODEL NUMBER 96-414-330)
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/30/2023
• Supplement Date Received by Manufacturer: 05/31/2024; 08/08/2024
• Initial Report FDA Received Date: 12/28/2023
• Supplement Report FDA Received Date: 06/25/2024; 08/22/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/03/2022
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown