MAUDE Adverse Event Report: LIVANOVA DEUTSCHLAND GMBH BUBBLE SENSOR 3/8 X 3/32 - B-CAPTA; MONITOR, BLOOD GAS, ONLINE

Model Number	96-414-340
Medical Device Problem Codes	Under-Sensing (1661); Low Readings (2460)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/09/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A.1.-a.5.There was no patient involvement.10: livanova deutschland manufactures the b-capta.The incident occurred in usa.The sensor was not detecting the bubble.The customer then put the sensor onto another ehlm and it failed on there too.Tried a different bubble sensor on both ehlm and it worked perfectly.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, the 3/8 arterial bubble sensor was not triggering alarm when tested (air in tube) during in service.There was no patient involvement.
Additional Manufacturer Narrative
To solve the issue a new sensor was shipped to the customer and successfully installed.The complained bubble sensor was inspected by manufacturer.A visual inspection was performed and it was detected that the tubing insert was detached and the sensor cable was damaged.No functional test and further analysis was possible since the lack of the insert doesn't allow the proper tubing adherence to the sensor lid and this would affect the test results.Considering that, upon opening of the packaging for the visual inspection, the sensor cable was found wrapped inside the sensor body where the tubing is located during procedure, it cannot be ruled out that the sensor insert and the cable got damaged when the sensor was packed for the shipment.Complaints database review and trend analysis was carried out and revealed that no concerning trend related to undersensing issue of the essenz bubble sensors has been detected.Based on troubleshooting performed on site, the root cause of the reported issue has been assigned to a defective bubble sensor.Considering that functional testing would have been affected by the mechanical damage, the exact root cause of the reported issue cannot be narrowed down more specifically.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 initial report.

• Brand Name: BUBBLE SENSOR 3/8 X 3/32 - B-CAPTA
• Common Device Name: MONITOR, BLOOD GAS, ONLINE
• Manufacturer (Section D): LIVANOVA DEUTSCHLAND GMBH; 14401 w 65th way; arvada
• 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: 19257756
• Report Number: 9611109-2024-00207
• Device Sequence Number: 11434361
• Product Code: DRY
• UDI-Device Identifier: 04033817902447
• UDI-Public: (01)04033817902447
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K202154
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Initial Reporter Occupation: Other
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 09/24/2024

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: 96-414-340
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/09/2024
• Supplement Date Received by Manufacturer: 08/29/2024
• Initial Report FDA Received Date: 05/07/2024
• Supplement Report FDA Received Date: 09/26/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/05/2023
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown