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

Model Number	044063700
Medical Device Problem Code	Disconnection (1171)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/30/2024
Type of Reportable Event	Malfunction
Event or Problem Description
Livanova usa inc.Received a report related to the disconnection of the y connector placed in the outlet line of the arterial filter.The issue occurred during priming with flow at 6 lpm.The line was re-connected by the perfusionist and the circuit used for the surgery.There was no patient involvement.
Additional Manufacturer Narrative
A.1.-a.5.There was no patient involvement.H11: livanova usa inc.Manufactures the perfusion pack.The incident occurred in annapolis, maryland.From customer point of view it seems that the line was not bonded as it should be.Livanova initiated an investigation.If any additional information pertinent to the reported event is received, it will be provided in a supplemental report.
Event or Problem Description
See initial report.
Additional Manufacturer Narrative
H11: according to drawing of the involved custom pack and the information provided by the customer, the disconnection occurred between the y connector code and the arterial filter outlet tubing, that should be bonded together during manufacturing.Unit was not available for investigation.The review of the complaints database identified that no other similar incidents were notified for concerned batch, neither a concerning trend was detected.Based on the available data, the most likely root cause of the complained event was an improper assembly of the arterial line to the connector, likely due to insufficient application of solvent in manufacturing.To prevent re-occurrence, the manufacturing personnel has been involved in a dedicated training meeting to discuss the specific event.

• Brand Name: PERFUSION PACK
• Common Device Name: SMART, PERFUSION PACKS, CONNECTORS, TUBING
• Manufacturer (Section D): LIVANOVA USA INC.; 14401 w 65th way; arvada CO 80004
• 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: 20307755
• Report Number: 1718850-2024-00038
• Device Sequence Number: 20781544
• Product Code: DWE
• UDI-Device Identifier: 00803622147050
• UDI-Public: (01)00803622147050(240)044063700(17)260404(10)2409500035(11)240404
• Combination Product (Y/N): N
• Initial Reporter State: MD
• 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): 12/13/2024

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: 04/04/2026
• Device Model Number: 044063700
• Device Lot Number: 2409500035
• 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: 08/30/2024
• Supplement Date Received by Manufacturer: 11/28/2024
• Initial Report FDA Received Date: 09/26/2024
• Supplement Report FDA Received Date: 12/19/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/04/2024
• 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