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

Model Number	23-07-50
Medical Device Problem Codes	Low Readings (2460); Deformation Due to Compressive Stress (2889)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/10/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A.1.-a.5.There was no patient involvement.H10: livanova deutschland manufactures the bubble sensor detector.The incident occurred in yokohama, japan.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 heater-cooler system 3t caused a short circuit, after its switching on.In detail, the breaker of the specific socket where the 3t system was plugged in tripped.The device was then switched back on and the issue happened again.There was no patient involvement.
Event or Problem Description
See intial report.
Additional Manufacturer Narrative
Through follow-up communication, livanova learned that bubble sensor was checked prior surgery and worked as expected.During surgery, an alarm occurred and the sensor was continuously alarming even if there was no bubble.Bubble sensor was removed from the tube and re-positioned and the situation did not improve.Medical team elected to substitute the sensor.After that, customer verified the sensor and informed livanova the pad of the sensor was dented.The sensor cannot be repaired.A device service history review has been performed and identified that the unit was manufactured in 2018 and no other similar event has been reported, neither concerning trend has been identified.The issue is a known failure that is related to silicone oil diffusion through cushions due to design issue and causing false alarms.The risk that deflated cushions might cause patient injury is improbable and therefore the event has been reassessed as not reportable.The risk is in the acceptable region.No specific action was currently deemed necessary.Livanova will keep monitoring the market.

• Brand Name: BUBBLE SENSOR DETECTOR
• Common Device Name: MONITOR AND/OR CONTROL, LEVEL SENSING, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): LIVANOVA DEUTSCHLAND; lindberghstrasse 25; munich
• Manufacturer (Section G): LIVANOVA DEUTSCHLAND GMBH; lindberghstrasse 25; munich 80309 ; GM 80309
• Manufacturer Contact: enrico greco ; 14401 w. 65th way; arvada, CO 80004
• MDR Report Key: 18417463
• Report Number: 9611109-2023-00665
• Device Sequence Number: 12724494
• Product Code: KRL
• UDI-Device Identifier: 04033817900597
• UDI-Public: (01)04033817900597(11)180821
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K955152
• 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): 03/12/2024

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: 23-07-50
• 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: 10/24/2023
• Supplement Date Received by Manufacturer: 02/15/2024
• Initial Report FDA Received Date: 12/29/2023
• Supplement Report FDA Received Date: 03/12/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/21/2018
• 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