MAUDE Adverse Event Report: LIVANOVA USA INC COBE SMARXT TUBING AND CONNECTORS; TUBING, PUMP, CARDIOPULMONARY BYPASS

Model Number	SC ST JOHNS SANTA MONICA CA 1
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Adult Respiratory Distress Syndrome (1696)
Date of Event	06/17/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
A.1.-a.5.Patients' information was not provided.H11: livanova usa manufactures the convenience pack.Ards is a common chronic failure of the lung leading ultimately to the ecmo support.Post market surveillance data analysis did not identify any similar event reported by other customers and there is no element pointing to a correlation between the use of livanova device and the reported ards.Based on current level of evidence and also on what has been clarified with the customer, there is no allegation against livanova product.The inquiry was submitted to livanova with the aim to ask if any other customer ever reported similar patient conditions.Therefore, the reported adverse event is not related to livanova product.If any additional information pertinent to the reported event is received, it will be provided in a supplemental report.
Event or Problem Description
Livanova usa received a report that, within the last month, two (2) patients have shown acute respiratory distress syndrome (ards) and were subsequently put on ecmo following the cases.Through follow up communication, the customer clarified that there is no allegation against livanova devices and that it was just an inquiry.However, livanova is conservatively reporting this event.
Additional Manufacturer Narrative
H.11 livanova followed up further with the customer and no additional relevant information were provided confirming what was reported in the initial report.Ards is a common chronic failure of the lung leading ultimately to the ecmo support.Post market surveillance data analysis did not identify any similar event reported by other customers and there is no element pointing to a correlation between the use of livanova device and the reported ards.Based on current level of evidence and also on what has been clarified with the customer, there is no allegation against livanova product.The inquiry was submitted to livanova with the aim to ask if any other customer ever reported similar patient conditions.Therefore, the reported adverse event is not related to livanova product.
Event or Problem Description
See initial report.
Event or Problem Description
See initial report.
Additional Manufacturer Narrative
H11: complaints database review revealed no further similar events for involved part number and batch lot, nor any similar inquiry was submitted by other customers.Dhr review has been performed and no deviation or non-conformity has been identified.Based on investigation findings, no device problem was confirmed.Issue was likely due to patient conditions and expected procedural complications, not correlated to the device.Therefore, the reported adverse event is not related to livanova product.The risk is in the acceptable region.No specific action was currently deemed necessary.Livanova will keep monitoring the market.

• Brand Name: COBE SMARXT TUBING AND CONNECTORS
• Common Device Name: TUBING, PUMP, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): LIVANOVA USA INC; 14401 w 65th way; arvada CO 80004
• Manufacturer (Section G): LIVANOVA USA INC.; 14401 w 65th way; arvada CO 80004
• Manufacturer Contact: annarita di lascio ; 14401 w. 65th way; arvada, CO 80004
• MDR Report Key: 22528760
• Report Number: 1718850-2025-90005
• Device Sequence Number: 17994626
• Product Code: DWE
• UDI-Device Identifier: 00803622146268
• UDI-Public: (01)00803622146268(17)270109(11)250109(240)044013605(10)2500900026
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K981613
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other
• Remedial Action: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 11/24/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Model Number: SC ST JOHNS SANTA MONICA CA 1
• Device Catalogue Number: 044013605
• Device Lot Number: 2500900026
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/17/2025
• Supplement Date Received by Manufacturer: 07/25/2025; 10/29/2025
• Initial Report FDA Received Date: 07/17/2025
• Supplement Report FDA Received Date: 08/20/2025; 11/24/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/09/2025
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown