MAUDE Adverse Event Report: LIVANOVA DEUTSCHLAND FLOW SENSOR 3/8¿ X 3/32¿; CONSOLE, HEART-LUNG MACHINE, CARDIOPULMONARY BYPASS

Model Number	96-414-240
Medical Device Problem Code	Device Sensing Problem (2917)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/23/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A.1.-a.5.There was no patient involvement.H11: livanova deutschland manufactures the flow sensor 3/8¿ x 3/32¿.The incident occurred in bydgoszcz, poland.Through follow-up communication with the customer, livanova learned that the calibration of flow sensor was successfully performed properly before procedure.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 stating that, during priming, the flow sensor, despite the stopped flow (manually clamping the drain between the revolution centrifugal blood pump head) and stopping the aortic and venous clamps, showed oscillating values in the display from one to almost two liter.The values did not stop and were constantly changing from positive to negative and back.There was no patient involvement.
Event or Problem Description
See initial report.
Additional Manufacturer Narrative
H11: a short video was provided by customer confirming significant oscillation (25-45% with respect to total set flow) of flow read when all lines were clamped with electrical clamps (arterial and venous) as well as manual clamp between revolution head and the flow sensor.Involved flow sensor was returned to livanova for investigation.Upon visual inspection, no defects were found on the hardware.Sensor was then connected to the essenz heart lung machine (hlm) and mapped as venous flow sensor.Sensor was mounted on the tubing in series with an existing flow sensor to check the read values.Calibration was performed manually clamping the line before and after each sensor.When establishing flow, both sensors were measuring almost the same value (as per the device instructions for use, the 3/8¿ flow sensor has an accuracy of ±7%, therefore the small discrepancy recorded was related to accuracy level).When stopping the pump, flow oscillated between small positive and negative values while reducing the flow, but it set at 0.0 lpm in few seconds when clamping the line between revolution head and sensor, and after the sensor (to simulate arterial clamp that was not mounted on the system).No device malfunction has been reproduced.Based on all the gathered information and considering that the reported issue has not been reproduced, it is reasonable to assume that the flow sensor was slower than customer expected to settle to the correct value and/or there was a sub-optimal closure of the manual clamp between the revolution head and the sensor.

• Brand Name: FLOW SENSOR 3/8¿ X 3/32¿
• 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: 20565943
• Report Number: 9611109-2024-00508
• Device Sequence Number: 20715858
• Product Code: DTQ
• UDI-Device Identifier: 04033817902485
• UDI-Public: (01)04033817902485(11)231220
• Combination Product (Y/N): N
• Initial Reporter Country: PL
• 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): 01/15/2025

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: 96-414-240
• 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: 10/01/2024
• Supplement Date Received by Manufacturer: 01/19/2025
• Initial Report FDA Received Date: 10/30/2024
• Supplement Report FDA Received Date: 01/16/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/20/2023
• 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