MAUDE Adverse Event Report: LIVANOVA DEUTSCHLAND BUBBLE DETECTOR SENSOR; CONSOLE, HEART-LUNG MACHINE, CARDIOPULMONARY BYPASS

Model Number 23-07-50

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

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

Event Date 01/09/2023

Event Type  malfunction  

Manufacturer Narrative

Livanova deutschland manufactures the bubble sensor detector.The incident occurred in berlin, germany.A livanova field service representative was dispatched to the facility to investigate the device.Bubble sensor was checked, contact problems were eliminated.Subsequent functional verification testing was completed without further issues and the unit was returned to service.Livanova initiated an investigation.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 detector sensor was defective.The issue occurred during priming.No additional information is available.It cannot be excluded that bubble sensors did not detect air bubble.There was no patient involvement.

Manufacturer Narrative

H10: through follow-up communication livanova learned the involved device serial number.Model and serial number have been added to the dedicated d.4 section.In addition, livanova learned that bubble sensor detector was triggering false alarm (the pump is stopped by the bubble alarm even if no air is present in the monitored line).The over-sensing issue has unlikely possibility to cause patient issue since 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.Therefore, for the above rationale the event has been reassessed as not reportable.It cannot be ruled out that the most likely root cause of the reported event is a temporary electrical failure, as a false contact, a bad/loose cable connection, or oxidation of electronics which was definitely solved during field service activity.

Event Description

See initial report.

• Brand Name: BUBBLE DETECTOR SENSOR
• Type of Device: CONSOLE, HEART-LUNG MACHINE, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): LIVANOVA DEUTSCHLAND; 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: 16324996
• MDR Text Key: 309131878
• Report Number: 9611109-2023-00055
• Device Sequence Number: 1
• Product Code: KRL
• UDI-Device Identifier: 04033817900597
• UDI-Public: (01)04033817900597(11)210708
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K955152
• 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: 02/08/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/08/2023
• 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
• Date Manufacturer Received: 03/27/2023
• Was Device Evaluated by Manufacturer?: Yes
• 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