MAUDE Adverse Event Report: LIVANOVA USA INC SMART TUBING AND CONNECTORS; TUBING, PUMP, CARDIOPULMONARY BYPASS

Catalog Number	627199102
Medical Device Problem Code	Disconnection (1171)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/03/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
No patient information has been provided.Livanova usa inc manufactures the complained circuit.The incident occurred in pittsburgh, pennsylvania, united states of america.Complained circuit has been discarded by the customer.If any additional information pertinent to the reported event is received, it will be provided in a supplemental report.Device discarded by the user.
Event or Problem Description
Livanova usa inc has received a report that, during a ecls support, two different events of line disconnection occurred on the same patient with the same tubing set.The first disconnection (present report) occurred shortly after initiation on (b)(6) 2022 from the outlet of a competitor oxygenator.The tubing set had been assembled dry as a standby setup.The tubing was pushed fully onto the oxygenator outlet connector and tie banded.The specific tie gun used was not recorded.Line pressure was appx 300mm hg.The line was not under tension.Support was resumed in 1-2 minutes after de-airing and reconnecting the circuit.The second disconnection occurred on (b)(6) 2022 and is being reported as a separated medwatch.There is no report of any patient injury.
Additional Manufacturer Narrative
Livanova received a report stating of outllet tubing disconnection during a procedure.No patient/user affected.Unit is not available.According to the technical documentation of the circuit, the involved connection is assembled by the customer.This was confirmed also through the event description details, livanova learned that the line involved was connected by the customer to the outlet of a quadrox oxy and tie banded.Indeed, the involved connection was not performed during the livanova manufacturing.The dhr review highlighted that the lot whose claimed product belong to was released as conform according to specifications.The same customer reported another similar event on the same lot 14 days later.The reported disconnection can be due to a deviation in the chemical characteristics of the tubing (supplied by an external supplier) or to an improper connection made by the customer.Investigation of similar previous events did not identify any tubing significant measurable deviation nor any other specific reoccurrence that could suggest a specific root cause (no specific reoccurrence in the disconnection points, blood pressures, connection types, connections made by livanova operators or by customers).However, it could be not ruled out that untestable manufacturing and chemical deviations may have contributed to disconnection.The risk is in the acceptable region.No action is deemed necessary.Livanova will keep monitoring the market.
Event or Problem Description
See initial report.

• Brand Name: SMART TUBING AND CONNECTORS
• Common Device Name: TUBING, PUMP, CARDIOPULMONARY BYPASS
• 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: 14166759
• Report Number: 1718850-2022-00033
• Device Sequence Number: 14708705
• Product Code: DWE
• UDI-Device Identifier: 00803622136573
• UDI-Public: (01)00803622136573(240)627199102(17)240229(10)2203200053
• Combination Product (Y/N): N
• Initial Reporter State: PA
• 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
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 07/21/2022

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: 02/29/2024
• Device Catalogue Number: 627199102
• Device Lot Number: 2203200053
• 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: 03/30/2022
• Supplement Date Received by Manufacturer: 06/28/2022
• Initial Report FDA Received Date: 04/21/2022
• Supplement Report FDA Received Date: 07/25/2022
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/01/2022
• 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: Male