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

Model Number	044002304
Medical Device Problem Code	Misassembled (1398)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A.1.-a.5.Patient information were not provided.H.10.Livanova manufactures the smart perfution tubing.The incident occurred in usa.If any additional information pertinent to the reported event is received, it will be provided in a supplemental report.This report was due on november 25, 2023; however, due to a network disruption at livanova, the ability to submit mdrs was lost on november 19, 2023, before this report was ready to submit.The report was prepared and submitted immediately following restoration of the livanova systems.
Event or Problem Description
Livanova was informed that, during a procedure, medical team found the yellow and white clamps were assembled incorrectly on cpg lines.Livanova was not informed of any patient impact.
Event or Problem Description
See initial report.
Additional Manufacturer Narrative
H10: a picture of the mis-assembly was provided by the customer, confirming the issue.A review of the complaints database did not reveal further similar events occurred on this pts pack code or concerned batch.Most likely root cause of the reported event was a manufacturing operator error during the assembly phase of this pts.As corrective action, manufacturing personnel will be involved in a dedicated training meeting awaring of customer complaint.

• Brand Name: SMART PERFUSION PACK
• Common Device Name: TUBING
• Manufacturer (Section D): LIVANOVA USA; 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: 18326340
• Report Number: 1718850-2023-00037
• Device Sequence Number: 7520289
• Product Code: DWE
• UDI-Device Identifier: 00803622153389
• UDI-Public: (01)00803622153389(240)044002304(17)240828(10)2324100031(11)230829
• Combination Product (Y/N): N
• Initial Reporter State: NC
• 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): 02/01/2024

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: 08/28/2024
• Device Model Number: 044002304
• Device Lot Number: 2324100031
• Was Device Available for Evaluation?: No
• 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: 10/26/2023
• Supplement Date Received by Manufacturer: 01/03/2024
• Initial Report FDA Received Date: 12/14/2023
• Supplement Report FDA Received Date: 02/01/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/29/2023
• 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