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	Low Readings (2460)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/02/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
There was no known patient involvement.Livanova deutschland manufactures the bubble detector sensor.The incident occurred in apopka, florida.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 during procedure a bubble detector sensor 3/8" malfunctioned.There was no patient injury.
Event or Problem Description
See initial report.
Additional Manufacturer Narrative
H10: despite several attempts, livanova was not able to retrieve additional information from the customer.No information regarding the type of malfunction and the service activity eventually performed by the hospital biomed was provided.Complaints database analysis revealed no similar event since unit installation in 2018.Due to the lack of information, the root cause of the reported event could not be established and remains unknown.If any additional information pertinent to the reported event is received, it will be provided in a supplemental report.

• Brand Name: BUBBLE DETECTOR SENSOR
• Common Device Name: MONITOR AND/OR CONTROL, LEVEL SENSING, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): LIVANOVA DEUTSCHLAND; lindberghstr. 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: 15894316
• Report Number: 9611109-2022-00623
• Device Sequence Number: 12437007
• Product Code: KRL
• UDI-Device Identifier: 04033817900597
• UDI-Public: (01)04033817900597(11)180606
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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): 12/01/2022

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: 11/02/2022
• Supplement Date Received by Manufacturer: 02/28/2023
• Initial Report FDA Received Date: 12/01/2022
• Supplement Report FDA Received Date: 03/29/2023
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/06/2018
• 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