MAUDE Adverse Event Report: LIVANOVA DEUTSCHLAND GMBH SORIN S3 BUBB DETECTOR

Model Number 23-07-50

Device Problems False Alarm (1013); Low Readings (2460)

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

Event Date 01/16/2024

Event Type  malfunction  

Manufacturer Narrative

A.1.-a.5.Patient information was not provided.H10: livanova deutschland manufactures the sorin s3 bubble detector.The incident occurred in united states of america.If any additional information pertinent to the reported event is received, it will be provided in a supplemental report.

Event Description

Livanova deutschland has received a report that, during a procedure, bubble sensor failed.There is no report of any patient injury.

Manufacturer Narrative

H10: through follow-up communication livanova learned that the issue claimed was related to an over-sensing generating false alarms.In case of bubble sensor triggering false bubble alarms, the pump is stopped by the bubble alarm even if no air is present in the monitored line.In such situations, the alarm can always be cleared/overridden by user, once the line is verified to be free of air, and the perfusion can be easily restarted.Thus, it is unlikely that a false bubble alarm will result in serious injury.Therefore, the event is being re-assessed as not reportable.A livanova field service representative was dispatched to the facility to investigate the device and could confirm the reported issue: bubble sensor alarm was reproducible.In order to solve the issue, the affected bubble sensor was replaced with a new one.Subsequent functional verification testing was completed without further issues and the unit was returned to service.Complaint database review revealed no further similar issues since unit installation in 2014.The issue was related to silicone oil diffusion through bubble sensor cushions causing false alarms.The risk of failure has been determined as acceptable.

Event Description

See initial report.

• Brand Name: SORIN S3 BUBB DETECTOR
• Type of Device: DETECTOR
• Manufacturer (Section D): LIVANOVA DEUTSCHLAND GMBH; lindberghstrasse 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: 18685071
• MDR Text Key: 335197214
• Report Number: 9611109-2024-00075
• Device Sequence Number: 1
• Product Code: KRL
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K955152
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 04/09/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/12/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 23-07-50
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/11/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/30/2012
• 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