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

Model Number	96-414-340
Medical Device Problem Codes	Break (1069); Low Readings (2460)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/12/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A.1.-a.5.There was no patient involvement.H11: livanova deutschland manufactures the bubble sensor detector.The incident occurred in (b)(6).Livanova initiated an investigation.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 was defective during procedure.No additional information is available.It cannot be excluded that bubble sensor did not detect air bubble.There was no patient involvement.
Event or Problem Description
See initial report.
Additional Manufacturer Narrative
H11: through follow up communication, livanova learned that the reported issue was related to the bubble sensor insert that got detached from the lid.In detail, the small black plastic disk fell out of the detector.Therefore, based on the information received, the event has been re-assessed as not reportable since this type of issue is promptly detectable by the user and it is unlikely to cause patient injury.The bubble sensor is manufactured by a supplier, who has been notified to address this specific failure.Following the sensors' investigation, the supplier introduced a primer into the gluing process to prevent the insert from detaching.The sensor was manufactured before the corrective action implementation, indeed for 3/8 x 3/32 bubble sensor the first serial number manufactured after the introduction of the primer is (b)(6).This involved serial number is instead (b)(6).Based on the above information, the reported failure has been traced back to a faulty supplied component.

• Brand Name: BUBBLE SENSOR DETECTOR
• Common Device Name: CONSOLE, HEART-LUNG MACHINE, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): LIVANOVA DEUTSCHLAND; lindberghstrasse 25; munich
• Manufacturer (Section G): LIVANOVA DEUTSCHLAND; lindberghstrasse 25; munich 80939 ; GM 80939
• Manufacturer Contact: enrico greco ; 14401 w. 65th way; arvada, CO 80004
• MDR Report Key: 20178094
• Report Number: 9611109-2024-00406
• Device Sequence Number: 15528443
• Product Code: DTQ
• UDI-Device Identifier: 04033817902447
• UDI-Public: (01)04033817902447(11)220419
• Combination Product (Y/N): N
• Initial Reporter State: TN
• Initial Reporter Country: US
• 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 Health Care Professional
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 10/23/2024

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: 96-414-340
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/12/2024
• Supplement Date Received by Manufacturer: 09/27/2024
• Initial Report FDA Received Date: 09/10/2024
• Supplement Report FDA Received Date: 10/24/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/19/2022
• 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