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

Model Number	96-414-320
Medical Device Problem Code	Low Readings (2460)
Health Effect - Clinical Code	Cardiovascular Dysfunction/Insufficiency (4445)
Date of Event	08/05/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
Livanova deutschland received a report that a cardioplegia bubble sensor alarmed five (5) different times during the initial dose of cardioplegia.No air was observed in all instances and the alarm was cleared.The patient was placed on a rvad device post cardiopulmonary bypass, purportedly due to myocardial protection.
Additional Manufacturer Narrative
H11: livanova deutschland manufactures the bubble sensor detector.The incident occurred in rochester, minnesota.Through follow-up communication with the customer, livanova learned the following additional information: - type of surgical procedure: cabg; - patient size (height, weight, age): 154cm / 92 kg / 80 years old; - cardioplegia route of administration: antegrade; - duration and interval of administration of cardioplegia: longest ischmic time 16" / 3 doses; - total aortic cross clamp duration: 61 minutes; - volume of cardioplegia: 1430 ml; - circuit size/type: 1/2 x 3/8, open; - cardioplegia type: del nido; - cardioplegia ratio: 1 to 4; - cardioplegia heat exchange temperature (degrees): 6-7 °c.- heater cooler set temperature (degrees): cooled to 32°c.- patient baseline conditions: cad, htn, hyperlipdemia, prediabetes, bmi 35, ami on admission.Based on livanova medical opinion, the patient had an ami (acute myocardial infarction) on admission.This is a serious predictor of worse outcomes in terms of myocardial injury and this may be the best explanation for the failing right ventricle leading to rvad.Recent myocardial infarction is considered a critical factor in the sts risk model.It significantly impacts the predicted risk of mortality and morbidity, reflecting the increased vulnerability of patients who have had a recent mi.The patient had multiple comorbidities which also may contribute to a worse outcome.Lastly, the total ischemic time was short (61 minutes).Adding to this 16-minute cpl re-infusions, there is no reason to think there was a poor myocardial protection which could explain the need to rvad support.In conclusion, most likely patient's clinical factors contributed to the failing heart right ventricle which led to the need of rvad support.If any additional information pertinent to the reported event is received, it will be provided in a supplemental report.
Additional Manufacturer Narrative
H11: a comprehensive root cause investigation for this bubble sensor false alarm issue has been conducted in collaboration with livanova research & development (r&d) department and the sensor's supplier.Through testing conducted in both controlled environments and clinical conditions across various sensors, the following potential root causes have been conclusively excluded: - sensor sensitivity deviation; - electromagnetic interference; - clinical and operational factors, including fluid dynamics, turbulence, and density.The testing confirmed that no performance anomalies were observed, and all results were aligned with the operational specifications, with no deviations identified.In addition, it was observed that alarms may be triggered in the absence of air, identifying the following potential causes: - polling cycle limitations: the sensor¿s polling frequency, while within specification limits, approaches the upper range of the sensor¿s processing capacity, which may contribute to unexpected alarms.- sensor reset due to communication variances: under specific communication conditions, the sensor¿s control module may request a sensor power cycle, potentially triggering an alarm state.A capa (reference ca-0020) has been initiated to further investigate the bubble sensor false alarm issue, which has been mitigated through the essenz hlm software release 1.5.1, addressing the currently identified potential causes.
Event or Problem Description
See initial report.

• 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: 20125721
• Report Number: 9611109-2024-00396
• Device Sequence Number: 11551349
• Product Code: DTQ
• UDI-Device Identifier: 04033817902423
• UDI-Public: (01)04033817902423(11)20221004
• Combination Product (Y/N): N
• Initial Reporter State: MN
• Initial Reporter Country: US
• PMA/510(K) Number: 1
• 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): 12/13/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: 96-414-320
• 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: 08/06/2024
• Supplement Date Received by Manufacturer: 11/29/2024
• Initial Report FDA Received Date: 09/03/2024
• Supplement Report FDA Received Date: 12/19/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/04/2022
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 80 YR
• Patient Sex: Unknown
• Patient Weight: 92 KG