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

Catalog Number	627392401
Medical Device Problem Code	Disconnection (1171)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/09/2021
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 usa.The device was received at livanova usa inc for investigation.Preliminary investigation confirmed the tubing thickness was in specification.If any additional information pertinent to the reported event is received, it will be provided in a supplemental report.
Event or Problem Description
Livanova usa inc.Has received a report that, about three minutes after the initiation of support, the tubing disconnected from the inlet of the oxygenator.The oxygenator was a maquet quadrox.The circuit was assembled dry and connections were double tie banded using a tie gun.Model and calibration status of the tie gun is unknown.
Event or Problem Description
See intial report.
Additional Manufacturer Narrative
Updated initial reporter.
Event or Problem Description
See intial report.
Additional Manufacturer Narrative
Livanova received a report stating that the tubing had disconnected from the inlet connector of another manufacturer oxygenator.The issue occurred about three minutes after the initiation of support.No patient affected.It was reported that the circuit was dry assembled and connections were double tie banded using a tie gun.Therefore, the connection between livanova tubing and the oxygenator was made by the customer.A review of the dhr did not identify any deviations, non-conformity or material scrap/requests relevant to the reported issue.The oxygenator and the disconnected tubing were returned to livanova for investigation.Visual inspection could not identify any connection issues between the tubing and the oxygenator.Moreover, wall thickness and id of the tubing was found to be within specification.Similar complaints have been registered in the last 12 months on different customers/pts codes.Based on all the gathered information, the most likely root cause of the reported tubing disconnection can be traced back to an alteration of the chemical / mechanical characteristics of the tubings (which are supplied by a livanova).However, this could be enhanced by the tubing not being properly secured to the oxygenator inlet.Supplier of the tubing has been formally notified of the issue.At the moment, no other corrective action is deemed necessary.Livanova will keep monitoring the market.

• Brand Name: TUBING, PUMP, CARDIOPULMONARY BYPASS
• Common Device Name: SMARXT TUBING AND CONNECTORS
• Manufacturer (Section D): LIVANOVA USA INC; 14401 w 65th way; arvada CO 80004
• MDR Report Key: 12128532
• Report Number: 1718850-2021-00036
• Device Sequence Number: 4723220
• Product Code: DWE
• UDI-Device Identifier: 00803622138331
• UDI-Public: (01)00803622138331(240)627392401(17)211130(10)1931100040
• 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 Health Care Professional
• Remedial Action: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 10/12/2021

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: 11/30/2021
• Device Catalogue Number: 627392401
• Device Lot Number: 1931100040
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/28/2021
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 06/10/2021
• Supplement Date Received by Manufacturer: 08/03/2021; 09/15/2021
• Initial Report FDA Received Date: 07/07/2021
• Supplement Report FDA Received Date: 08/03/2021; 10/13/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1