MAUDE Adverse Event Report: LIVANOVA USA INC PERFUSION PACK; TUBING

Model Number	044005203
Medical Device Problem Code	Disconnection (1171)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/01/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A.5.There was no patient involvement.H.11.Livanova manufactures the perfusion pack.Picture of the disconnected part were provided and disconnection occurred at the y connectors in the cardioplegia line (solvent bonded to tubing in manufacturing).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 the cardioplegia line set fell apart at del nido bridge post case.Medical team was not on pump and there was no patient involvement.
Additional Manufacturer Narrative
Following to a livanova medical assessment meeting, it was agreed that the case has unlikely potentiality to cause a patient injury since in the disconnection occurred post procedure.Therefore, the event is re-assessed as not reportable.The risk is in the acceptable region.No specific action was currently deemed necessary.Livanova will keep monitoring the market.

• Brand Name: PERFUSION PACK
• Common Device Name: TUBING
• 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: 20809272
• Report Number: 1718850-2024-00043
• Device Sequence Number: 9301975
• Product Code: DWE
• UDI-Device Identifier: 00803622155468
• UDI-Public: (01)00803622155468(240)044005203(17)260515(10)2427000057(11)240926
• Combination Product (Y/N): N
• Initial Reporter State: AL
• 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
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 01/02/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 05/15/2026
• Device Model Number: 044005203
• Device Lot Number: 2427000057
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/01/2024
• Supplement Date Received by Manufacturer: 12/05/2024
• Initial Report FDA Received Date: 11/29/2024
• Supplement Report FDA Received Date: 01/03/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/26/2024
• 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
• Patient Sex: Unknown