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

Catalog Number	044021202
Medical Device Problem Code	Disconnection (1171)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/23/2021
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 (b)(6), united states of america.Device availability was not clarified.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, during a bypass, a one-way valve disconnected from the tubing.According to customer, the patient lost about 2l of blood.Follow up information with the customer are ongoing.There is no report of any patient injury.
Event or Problem Description
See initial report.
Additional Manufacturer Narrative
Customer reported condition "during bypass, the one-way valve assembled on the inspire integrated arterial filter disconnected from the tubing during a procedure.The patient lost about 2l of blood." complained line was returned to livanova for investigation.The line was disinfected and visual inspected.Visual inspection identified the tubing slightly backed off the one-way valve.The tubing connected to the inlet side could be easily disconnected by hand.Inspection under uv light revealed both ends of the tubing connected to the valve appeared to have solvent present.However, the solvent on the tubing side that was disconnected did not appear to be applied uniformly around the connection.According to internal procedure, solvent shall be applied to both ends of the valve.Source of the issue appears related to an error during manufacturing.
Additional Manufacturer Narrative
Livanova received a report that, during a bypass, a one-way valve line disconnected from the tubing.According to customer, the patient lost about 2l of blood.There is no report of any patient injury.The dhr review confirmed the complained lot was released as conforming to product specifications.No other similar complaints on this pts code in the last 12 months, thus the reported case is isolated.Visual inspection of the returned line suggested the solvent was not applied uniformly around the connection that eventually disconnected.Based on this, it cannot be ruled out that the root cause was traced back to an error during manufacturing.The personnel will be involved in a dedicated training meeting.No other specific action was currently 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
• MDR Report Key: 12208955
• Report Number: 1718850-2021-00040
• Device Sequence Number: 14566584
• Product Code: DWE
• UDI-Device Identifier: 00803622130830
• UDI-Public: (01)00803622130830(240)044021202(17)230531(10)2113100081
• Combination Product (Y/N): N
• Initial Reporter State: VA
• 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): 09/21/2021

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: 05/31/2023
• Device Catalogue Number: 044021202
• Device Lot Number: 2113100081
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 06/24/2021
• Supplement Date Received by Manufacturer: 08/27/2021; 08/27/2021
• Initial Report FDA Received Date: 07/22/2021
• Supplement Report FDA Received Date: 08/27/2021; 09/22/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1