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

Catalog Number	044073201
Medical Device Problem Code	Disconnection (1171)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/13/2024
Type of Reportable Event	Malfunction
Event or Problem Description
Livanova usa inc.Received a report that in (b)(4) units belonging to a customized perfusion tubing system venous line fell off the reservoir in the middle of the procedure.There was no patient injury.
Additional Manufacturer Narrative
A.1.-a.5.There was no patient involvement.H.10.Livanova usa inc manufactures pts tubing pack.The incident occurred in (b)(6) illinois.Through follow-up communication livanova learned that the patient wasn¿t affected due to the perfusionist quick reaction.The customer also stated that the vent lines have fallen off of the reservoir as well a few times after the pumps were dry set up and confirmed that the reservoir was not over pressurized.In addition, affected packs cannot be investigated because they were thrown out by the customer.If any additional information pertinent to the reported event is received, it will be provided in a supplemental report.
Additional Manufacturer Narrative
H.11:as per pts drawing, affected connections to inspire reservoir # (b)(4) are left to the customer.Analysis of complaints database revealed that no other similar case was notified for batch concerned, nor for this pts pn, neither a concerning trend has been identified.Based on the above, considering that complained connections are not performed in livanova manufacturing and that no physical investigation could be performed on affected units, the most likely root cause of the event was an improper connection assembled by the customer at their facility.No specific action was currently deemed necessary.Livanova maintains and documents periodic customer events monitoring process in order to evaluate actions for products improvement.
Event or Problem Description
See initial report.

• Brand Name: PTS TUBING PACK
• Common Device Name: PERFUSION TUBING SET
• 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: 19085877
• Report Number: 1718850-2024-00027
• Device Sequence Number: 7652356
• Product Code: DWE
• UDI-Device Identifier: 00803622154874
• UDI-Public: (01)00803622154874(240)044073201(17)260218(10)2405000026(11)240219
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K881330
• 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): 11/25/2024

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: 02/18/2026
• Device Catalogue Number: 044073201
• Device Lot Number: 2405000026
• 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: 03/14/2024
• Supplement Date Received by Manufacturer: 11/25/2024
• Initial Report FDA Received Date: 04/11/2024
• Supplement Report FDA Received Date: 11/25/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/19/2024
• 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