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

Model Number	23-45-20
Medical Device Problem Code	Under-Sensing (1661)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/08/2024
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 riyadh, saudi arabia.Through follow-up communication with the customer, livanova learned that the involved bubble sensor has been checked by customer technical engineer and no issue was noticed.The unit is in daily use inside the operating room and no issue had been reported by the end-user.If any additional information pertinent to the reported event is received, it will be provided in a supplemental report.H3 other text : device inspected by customer engineer.
Event or Problem Description
Livanova deutschland has received a report that, during a procedure, a bubble sensor detector was activated upon the detection of an air bubble, however, later, it could not have detected it since the end-user noticed a massive air in the circulation.There was no patient injury.
Event or Problem Description
See initial report.
Additional Manufacturer Narrative
As per s5 instruction for use, the 3/8¿ bubble sensor is designed to detect micro bubbles with diameter greater than 4 mm.Log-files from the main pump which was active during the operation were provided for analysis.End-user reported that the event occurred from 8:00 to 14:00 on (b)(6) 2024, however these data in the log files have been partially overwritten.From the log of the pump it emerged that on the date of the event, at 13:01:12, the pump was disconnected from the linked bubble sensor.This can happens if the control function on the pump is switched off improperly, or if there is a failure of the device linked to the pump or if there is a can bus interruption.In these cases, the control display module (cdm) of the s5 system panel shows the message "no monitoring/control pump 1".Customer was asked if this message was noticed, and customer could neither confirm nor deny.The last section of the log of the pump begins with the event stored at 13:18:55 on (b)(6) and does not go back before that time.It¿s possible that the other lines of the log were already overwritten when this was extracted.Therefore, no other information could be retrieved for the time frame 8:00-15:00, as only four lines of the logs were included in this interval.No bubble stop was recorded from 13:18 to 14:57, but there were some later during procedure.A device service history review has been performed and identified that the unit was manufactured in 2019 and no other similar event has been reported, neither concerning trend has been identified.Based on the above, considering that no hardware failure was confirmed, the most likely root cause of the reported event is a user error in switching off improperly the control function.However, it cannot be totally ruled out that a temporary malfunction of the bubble sensor occurred, that was definitely fixed during service activity.No other action is deemed necessary.The risk is in the acceptable region.Livanova maintains and documents periodic customer events monitoring process to evaluate actions for products improvement.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: 18825128
• Report Number: 9611109-2024-00111
• Device Sequence Number: 7786208
• Product Code: DTW
• UDI-Device Identifier: 04033817900665
• UDI-Public: (01)04033817900665(11)190820
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K071318
• 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): 07/18/2024

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: 23-45-20
• 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: 02/04/2024
• Supplement Date Received by Manufacturer: 06/28/2024
• Initial Report FDA Received Date: 03/04/2024
• Supplement Report FDA Received Date: 07/18/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/20/2019
• 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