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

Model Number	23-07-50
Medical Device Problem Code	Low Readings (2460)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/20/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
There was no patient involvement.Livanova deutschland manufactures the bubble sensor detector.The incident occurred in (b)(6).Through follow-up communication livanova learned that the device stopped sensing.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 that a bubble sensor detector was defective.There was no patient involvement.
Additional Manufacturer Narrative
As per field service technician notes, a new bubble sensor has been sent to the customer who will be replacing it themselves.Based on all the above facts and similar event reported by other customers, 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.The risk is in the acceptable region.No specific action was currently deemed necessary.Livanova will keep monitoring the market.
Event or Problem Description
See intial report.

• 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; lindberghstrasse 25; munich 80309 ; GM 80309
• Manufacturer Contact: enrico greco ; 14401 w 65th way; arvada, CO 80004
• MDR Report Key: 16396048
• Report Number: 9611109-2023-00074
• Device Sequence Number: 6384742
• Product Code: KRL
• UDI-Device Identifier: 04033817900597
• UDI-Public: (01)04033817900597(11)170426
• Combination Product (Y/N): N
• Initial Reporter State: GA
• 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): 04/26/2023

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: 01/20/2023
• Supplement Date Received by Manufacturer: 03/31/2023
• Initial Report FDA Received Date: 02/17/2023
• Supplement Report FDA Received Date: 04/27/2023
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/26/2017
• 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