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

Catalog Number	044009500
Medical Device Problem Code	Disconnection (1171)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/13/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The complained circuit was not made available for investigation.Livanova usa inc manufactures the complained circuit.The incident occurred in (b)(6) united states.The involved parts were not made available for return.The involved connection is not pre-assembled and it was not tied banded by the customer as suggested by the instruction for use.A review of the dhr did not identify any deviations or non-conformities relevant to the reported issue.Based on the investigations performed for similar cases, the root cause of the reported event was traced back to an alteration of the chemical / mechanical characteristics of the tubings (which are purchased by a livanova supplier).The supplier has been formally informed of the event.The risk is acceptable.Livanova will keep monitoring the market.
Event or Problem Description
Livanova usa inc.Has received a report that, during the procedure the inlet of the oxygenator tubing disconnected from the cardiopulmonary machine.The system is all preconnected except this pressure tubing that dislodged during the procedure.Patient outcome was not provided.A 3500a report (ref (b)(4)) was received at livanova on 16 mar 2021.

• Brand Name: SMARXT TUBING AND CONNECTORS
• Common Device Name: TUBING, PUMP, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): LIVANOVA USA INC; 14401 w 65th way; arvada CO 80004
• MDR Report Key: 11671616
• Report Number: 1718850-2021-00028
• Device Sequence Number: 16890866
• Product Code: DWE
• UDI-Device Identifier: 00803622112324
• UDI-Public: (01)00803622112324(240)044009500(17)220930(10)2027400017
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• 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,other
• Initial Reporter Occupation: Other Health Care Professional
• Remedial Action: Other
• Type of Report: Initial
• Report Date (Section B): 03/16/2021

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: 09/30/2022
• Device Catalogue Number: 044009500
• Device Lot Number: 2027400017
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/16/2021
• Initial Report FDA Received Date: 04/15/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 67 YR