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

Catalog Number	044003201
Medical Device Problem Code	Disconnection (1171)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/22/2021
Type of Reportable Event	Malfunction
Event or Problem Description
Livanova usa inc has received a report that, during a priming, the customer intentionally applied some back pressure was to the circuit to test it and the arterial line disconnected from the oxygenator.After disconnection, the customer has reconnected the line, tie banded it, and continued to pressure test it without any recurrence.According to customer, at the end of the case, the connection that disconnected were easier to loosen than normal.There is no report of any patient involvement.
Additional Manufacturer Narrative
No patient involvement.Livanova usa inc manufactures the complained circuit.The incident occurred in (b)(6), united states of america.Device was not made available 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
See intial report.
Additional Manufacturer Narrative
According to the circuit technical documentation, the connection that was complained to have disconnected is done by the customer.No physical investigation on the connection could be done since the circuit was not made available for investigation.Review of the livanova complaint database did not identify any other similar complaint relevant to the same circuit item code thus excluding a systematic issue.Based on the available information, an overpressure condition at the oxygenator outlet, or a deviation in the chemical characteristics of the tubing or a not proper connection made by the customer are the most probable root causes.Since no device malfunction could be confirmed and the risk is in the acceptable region, no corrective action is deemed necessary.Livanova will keep monitoring the market for similar events.

• 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: 12672319
• Report Number: 1718850-2021-00046
• Device Sequence Number: 3750739
• Product Code: DWE
• UDI-Device Identifier: 00803622143083
• UDI-Public: (01)00803622143083(240)044003201(17)230331(10)2109000010
• Combination Product (Y/N): N
• Initial Reporter State: NC
• 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): 12/20/2021

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: 03/31/2023
• Device Catalogue Number: 044003201
• Device Lot Number: 2109000010
• Was Device Available for Evaluation?: No
• 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: 09/22/2021
• Supplement Date Received by Manufacturer: 11/22/2021
• Initial Report FDA Received Date: 10/21/2021
• Supplement Report FDA Received Date: 12/20/2021
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/31/2021
• 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