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

Catalog Number 044073201

Device Problem Disconnection (1171)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 03/13/2024

Event Type  malfunction  

Event 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.

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.

• Brand Name: PTS TUBING PACK
• Type of Device: 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
• MDR Text Key: 340701076
• Report Number: 1718850-2024-00027
• Device Sequence Number: 1
• Product Code: DWE
• UDI-Device Identifier: 00803622154874
• UDI-Public: (01)00803622154874(240)044073201(17)260218(10)2405000026(11)240219
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K881330
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 04/10/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/11/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• 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
• Date Manufacturer Received: 03/14/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 02/19/2024
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1