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

Catalog Number	627285601
Medical Device Problem Code	Misassembled (1398)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/30/2024
Type of Reportable Event	Malfunction
Event or Problem Description
Livanova received a report about white and red clamps were placed on the wrong lines discovered during priming by perfusionist.There is no report of patient injury.
Additional Manufacturer Narrative
A.1.-a.5.There was no known patient involvement.H11: livanova initiated an investigation.If any additional information pertinent to the reported event is received, it will be provided in a supplemental report.
Additional Manufacturer Narrative
A review of the complaints database revealed similar events occurred on this customized pack code (previously reported as 1718850-2024-00022 and 1718850-2024-00041).Technical documentation of the customized pack code has clear indication of clamp assembly.Based on the above facts, the most likely root cause of the reported event was a manufacturing operator error during the assembly phase of this pts.The personnel of the manufacturing line will be involved in a dedicated training meeting to discuss customer complaint.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: SMART, PERFUSION PACKS, CONNECTORS, 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: 20804065
• Report Number: 1718850-2024-00042
• Device Sequence Number: 9935005
• Product Code: DWE
• UDI-Device Identifier: 10803622119887
• UDI-Public: (01)10803622119887(240)627285601(17)260628(10)2418000064(11)240628
• Combination Product (Y/N): N
• Initial Reporter State: OH
• 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
• Type of Report: Initial,Followup
• Report Date (Section B): 01/29/2025

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: 06/28/2026
• Device Catalogue Number: 627285601
• Device Lot Number: 2418000064
• 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: 10/30/2024
• Supplement Date Received by Manufacturer: 12/31/2024
• Initial Report FDA Received Date: 11/28/2024
• Supplement Report FDA Received Date: 01/29/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/28/2024
• 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
• Patient Sex: Unknown