MAUDE Adverse Event Report: LIVANOVA USA INC. CARDIOPLEGIA PACK; SMART, PERFUSION TUBING PACKS

Catalog Number	044009103
Medical Device Problem Code	Air/Gas in Device (4062)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	11/04/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
Livanova usa inc.Received a report related to an air ingress into a perfusion tubing system (pts) pack.In detail, cardioplegia line was primed and flushed with no leaks noted when over-pressurized while in priming mode.Once cross clamp was on, while delivering the cardioplegia solution to the patient, the delivery system and line filled with air.Delivery was then stopped and attempted to flush air to the field.However, more air came into delivery system.Therefore, cross clamp was removed.Patient was defibrillated and cardioplegia system was exchanged for new one.New cardioplegia circuit was primed and flushed to the field.Cross clamp was placed and cardioplegia was delivered with no air issues.
Additional Manufacturer Narrative
A.1.-a.5.Patient information was not provided.H11: livanova usa inc.Manufactures the cardioplegia pack.The incident occurred in (b)(6).Through follow-up communication livanova learned that the affected unit is not available for investigation.If any additional information pertinent to the reported event is received, it will be provided in a supplemental report.
Additional Manufacturer Narrative
H11: by reviewing the complaints database, no further similar events have been recorded on this perfusion tubing system (pts) catalogue number nor a concerning trend has been identified.Review of the device history record (dhr) for the affected lot did not reveal any deviation or non-conformity.Based on the available information and without the part to investigate the root cause of the event cannot be established.Considering that no issue occurred during priming, it is unlikely that a defective component or connection was initially present on the cardioplegia line, but a defect could have originated due to stresses and manipulation applied during procedure.
Event or Problem Description
See initial report.

• Brand Name: CARDIOPLEGIA PACK
• Common Device Name: SMART, PERFUSION TUBING PACKS
• 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: enrico greco ; 14401 w. 65th way; arvada, CO 80004
• MDR Report Key: 20830131
• Report Number: 1718850-2024-00045
• Device Sequence Number: 14461141
• Product Code: DWE
• UDI-Device Identifier: 00803622142550
• UDI-Public: (01)00803622142550(240)044009103(17)260227(10)2405900038(11)240228
• Combination Product (Y/N): N
• Initial Reporter State: LA
• 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): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 02/26/2025

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
• Operator of Device: Health Professional
• Device Expiration Date: 02/27/2026
• Device Catalogue Number: 044009103
• Device Lot Number: 2405900038
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/02/2024
• Supplement Date Received by Manufacturer: 01/31/2025
• Initial Report FDA Received Date: 12/03/2024
• Supplement Report FDA Received Date: 02/27/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/28/2024
• 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): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown