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

Model Number	23-07-50
Medical Device Problem Code	Device Sensing Problem (2917)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/25/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
There was no patient involvement.Livanova deutschland manufactures the bubble detector sensor.The incident occurred in arlington, texas.If any additional information pertinent to the reported event is received, it will be provided in a supplemental report.
Event or Problem Description
Livanova received report that a bubble detector sensor malfunctioned during setup.Customer requested replacement of the sensor.No other detail was provided and a reportable malfunction cannot be excluded.There was no patient involvement.
Additional Manufacturer Narrative
Livanova received a report about a bubble sensor malfunction.No patient/user affected.Livanova field service technician was dispatched to customer facility and confirmed that bubble sensor cushions were deflated.A new bubble sensor was installed and the s5 was released at its expected functions.The unit is installed since 2016 and an analysis of the complaint database did not reveal further events related to this bubble sensor.The issue is a known failure that is related to silicone oil diffusion through cushions causing false alarms, that was investigated by the rci 2015-15 (deflated bubble sensor cushions).Investigation revealed that the oil diffusion through cushions is a design problem.Based on available information, it can be reasonably concluded that the reported issue was about deflated cushion leading to oversensing of the bubble sensor.This issue is not likely to result in serious injury since a false alarm can always be cleared by the user once the line has been verified to be free of air and perfusion can be easily restarted.In addition, it is also possible to perform override of the monitoring function.Therefore, the event is re-evaluated as not reportable.The risk is in the acceptable region.No corrective action is deemed necessary.Livanova will keep monitoring the market.
Event or Problem Description
See intial report.

• Brand Name: BUBBLE DETECTOR SENSOR
• Common Device Name: MONITOR AND/OR CONTROL, LEVEL SENSING, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): LIVANOVA DEUTSCHLAND; lindberghstrasse 25; munich
• Manufacturer (Section G): LIVANOVA DEUTSCHLAND; lindberghstrasse 25; munich 80309 ; GM 80309
• Manufacturer Contact: enrico greco ; 14401 w 65th way; arvada, CO 80004
• MDR Report Key: 15446296
• Report Number: 9611109-2022-00473
• Device Sequence Number: 7529825
• Product Code: KRL
• UDI-Device Identifier: 04033817900597
• UDI-Public: (01)04033817900597(11)160304
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• 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): 11/30/2022

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: 08/25/2022
• Supplement Date Received by Manufacturer: 11/02/2022
• Initial Report FDA Received Date: 09/19/2022
• Supplement Report FDA Received Date: 12/01/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/04/2016
• 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