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	10/29/2024
Type of Reportable Event	Malfunction
Event or Problem Description
Livanova received a report about the red and white "roberts" clamps where put on the wrong lines during assembly.The red were placed where the white should be and the white were placed where the red should be.This has occurred on three packs in the same lot number.
Additional Manufacturer Narrative
H11: 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: a review of the complaints database revealed that a similar event was also reported on this lot number (mfr #1718850-2024-00042), for a total of 4 packs affected out of 24 manufactured.Involved perfusion tubing system (pts) drawing (revision l) has clear indication of clamp assembly.Based on all the above, the most likely root cause of the reported event was a manufacturing operator error during the assembly phase of this pts.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.
• 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: 20794781
• Report Number: 1718850-2024-00041
• Device Sequence Number: 7791230
• 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
• Type of Report: Initial,Followup
• Report Date (Section B): 01/30/2025

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?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/29/2024
• Supplement Date Received by Manufacturer: 12/31/2024
• Initial Report FDA Received Date: 11/27/2024
• Supplement Report FDA Received Date: 01/30/2025
• 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