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	Under-Sensing (1661)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/01/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
There was no patient involvement.Serial number is unknown.This information will be provided in a supplemental report if made available.As the serial number is unknown, the device manufacture date could not be determined.This information will be provided in a supplemental report if made available.Livanova deutschland manufactures the bubble detector sensor.The incident occurred in cleveland, ohio.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 during bypass the perfusionist noticed that the bubble sensor showed a yellow ¿!¿ on the display control panel and was not reading.A plenty of ultrasonic gel was added and it worked temporarily but then gave a ¼¿ symbol with yellow "!".The bubble sensor was set on large size.There was no patient injury.
Event or Problem Description
See initial report.
Additional Manufacturer Narrative
Through follow-up communication livanova learned the model /serial number and udi code of device which have been added to the dedicated d.4 section.The manufacturing date of device has been added accordingly to h.4 section.H.10: through a follow up communication it was learnt that the sensor was tested before starting the procedure, as recommended in the s5 instruction for use, but it stopped working during procedure.Reportedly, the sensor correctly worked during the last two procedure it was used in.Moreover, it was reported that the ultrasonic gel was correctly applied on the 3/8 bubble sensor.The reported malfunction can be caused by: defective bubble sensor cable; defective bubble sensor module; bubble sensor not properly connected to its module (user error).A livanova field service technician was dispatched to the customer facility.The reported issue could be reproduced, ruling out a user error as cause of the event.Picture confirming the issue was provided by the authorized field service technician.A new bubble sensor was installed and the unit was then tested.No deviations were found when using the new bubble sensor.The new bubble sensor was therefore put in service and the entire s5 returned in its expected function.Based on collected information, the root cause of the reported malfunction is traced back to a defective bubble sensor.Most likely, a defective bubble sensor cable caused the reported event.

• 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: 15299831
• Report Number: 9611109-2022-00436
• Device Sequence Number: 17968775
• Product Code: KRL
• UDI-Device Identifier: 04033817900597
• UDI-Public: (01)04033817900597(11)220610
• Combination Product (Y/N): N
• Initial Reporter State: OH
• 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): 08/26/2022

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: 08/01/2022
• Supplement Date Received by Manufacturer: 09/22/2022
• Initial Report FDA Received Date: 08/26/2022
• Supplement Report FDA Received Date: 10/20/2022
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/10/2022
• 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
• Patient Sex: Unknown