MAUDE Adverse Event Report: LIVANOVA DEUTSCHLAND GMBH BUBBLE SENSOR 1/4 X 1/16; CONSOLE, HEART-LUNG MACHINE, CARDIOPULMONARY BYPASS

Model Number 96-414-330

Device Problem Low Readings (2460)

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

Event Date 11/29/2023

Event Type  malfunction  

Manufacturer Narrative

A.1.-a.5.Patient information were not provided.H10: livanova deutschland manufactures the bubble sensor.The incident occurred in ireland.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; it stopped to alarm.The issue occurred at setup.Restart of the unit cleared the issue.There was no patient involvement.

• Brand Name: BUBBLE SENSOR 1/4 X 1/16
• Type of Device: CONSOLE, HEART-LUNG MACHINE, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): LIVANOVA DEUTSCHLAND GMBH; lindberghstrasse 25; munich 41037 ; GM 41037
• 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: 18407710
• MDR Text Key: 331488666
• Report Number: 9611109-2023-00660
• Device Sequence Number: 1
• Product Code: DTQ
• UDI-Device Identifier: 04033817902430
• UDI-Public: (01)04033817902430(11)221103
• Combination Product (y/n): N
• Reporter Country Code: EI
• PMA/PMN Number: K232291
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Other
• Remedial Action: Other
• Type of Report: Initial
• Report Date: 12/28/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/28/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 96-414-330
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 11/30/2023
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 11/03/2022
• 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