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

Catalog Number	627382901
Medical Device Problem Code	Disconnection (1171)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
No patient information has been provided.Event date is unknown livanova usa inc manufactures the complained circuit.The incident occurred in (b)(6), united states of america a.Device has been requested for investigation.If any additional information pertinent to the reported event is received, it will be provided in a supplemental report.
Event or Problem Description
The pump circuit was set-up in the normal configuration and they were on by-pass.The centrifugal tubing was attached and ti-banned to the terumo oxygenator, and suddenly the tubing became disconnected to the inlet valve on the oxygenator.The perfusionist quickly re-attached the tubing, with a very small amount of blood being lost in the process of re-attaching the tubing.This was the first time this had happened with the tubing and the oxygenator.
Additional Manufacturer Narrative
Livanova received a report stating that, during a procedure, the tubing disconnected from the oxygenator inlet.The unit was requested for further investigation.When the device was received at livanova, it was identified it contained the device of another complaint.Livanova is following up with the customer to confirm the complained device is not available.According to the technical documentation of the circuit, the involved connection is assembled by the customer.Therefore, 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.The dhr review highlighted that the lot whose claimed product belong to was released as conform according to specifications.The circuit item code was never complained by the customer, so the event is isolated.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.H3 other text : incorrect device returned.
Event or Problem Description
See intial 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: 13791466
• Report Number: 1718850-2022-00026
• Device Sequence Number: 19247767
• Product Code: DWE
• UDI-Device Identifier: 00803622136597
• UDI-Public: (01)00803622136597(240)627382901(17)220430(10)2010000043
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• 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 Health Care Professional
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 07/12/2022

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: 04/30/2022
• Device Catalogue Number: 627382901
• Device Lot Number: 2010000043
• Was Device Available for Evaluation?: Yes
• 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: 02/15/2022
• Supplement Date Received by Manufacturer: 06/15/2022
• Initial Report FDA Received Date: 03/17/2022
• Supplement Report FDA Received Date: 07/14/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 04/09/2020
• 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