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

Model Number 23-07-50

Device Problem Low Readings (2460)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 01/23/2024

Event Type  malfunction  

Manufacturer Narrative

A.1.-a.5.There was no patient involvement.H10: livanova deutschland manufactures the bubble sensor detector.The incident occurred in denver, colorado.Through follow-up communication, livanova learned that the unit was tested by customer engineer and it was not working.In addition, the failure of the bubble detector occurred when it was placed on another unit, but customer did not remember what unit.A livanova field service representative was dispatched to the facility to investigate that was tested with scp/scpc which it is linked to, without reproduce the reported issue.Preventive maintenance was completed and also functional verification testing without issues.The unit was returned to service.Therefore, based on the information above, a temporary malfunction of the bubble sensor cannot be excluded.However, since it was reported that the sensor was not used on the linked scp, it cannot be ruled out that the user connected improperly the cable of the sensor to another equipment or the firmware of the other device was incompatible with the one of the complained bubble sensor.If any additional information pertinent to the reported event is received, it will be provided in a supplemental report.

Event Description

Livanova deutschland received a report that a bubble sensor detector did not detect air bubbles during procedure.There was no patient injury.

Manufacturer Narrative

A device service history review has been performed and identified that the unit was manufactured in 2020 and no other similar event has been reported, neither concerning trend has been identified.The most likely root cause of the reported issue is an improper connection of the sensor cable to the other equipment or the incompatibility of the firmware between the unknown used console and the complained bubble sensor.However, a temporary malfunction of the bubble sensor cannot be totally ruled out.The risk is in the acceptable region.No specific action was currently deemed necessary.Livanova will keep monitoring the market.

Event Description

See intial report.

• Brand Name: BUBBLE SENSOR DETECTOR
• Type of Device: MONITOR AND/OR CONTROL, LEVEL SENSING, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): LIVANOVA DEUTSCHLAND; lindberghstrasse 25; munich
• 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: 18738907
• MDR Text Key: 336853584
• Report Number: 9611109-2024-00083
• Device Sequence Number: 1
• Product Code: KRL
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Other Health Care Professional
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 04/11/2024

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
• Device Operator: Health Professional
• Device Model Number: 23-07-50
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 01/23/2024
• Initial Date FDA Received: 02/20/2024
• Supplement Dates Manufacturer Received: 03/18/2024
• Supplement Dates FDA Received: 04/16/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/30/2020
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1