MAUDE Adverse Event Report: LIVANOVA USA INC DEACONESS MED SPOKANE WA 1; SMART, PERFUSION PACKS, CONNECTORS, TUBING

Catalog Number	044033501
Medical Device Problem Codes	Disconnection (1171); Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/14/2023
Type of Reportable Event	Malfunction
Event or Problem Description
Livanova usa has received a report that the 1/4 inch tubing on the inlet on top of the reservoir disconnected.The tube was with tie bands.There is no report of any patient injury.
Additional Manufacturer Narrative
Patient information was not provided.Livanova usa inc manufactures the customized perfusion pack.Livanova initiated an investigation.If any additional information pertinent to the reported event is obtained, it will be provided in a supplemental report.
Additional Manufacturer Narrative
Claimed part was not available for investigation, nor visual evidence of the connector was provided.Through follow-up communication, livanova learned that involved connection was the 1/4" line assembled on the suction inlet port of cardiotomy section.The failure was detected during blood collection phase.No patient injury and no additional medical intervention occurred.The same failure re-occurred with same circuit item code.Dhr review confirmed the circuit was released conforming to product specifications.Reservoir connections are 100% verified during circuit assembly and no deviation was recorded during manufacturing.The most probable root causes are: (i) an overpressure condition at the disconnection point; (ii) tubing not fully pushed on the hvr suction barb connector or (iii) moulding defect of hvr barb connector, not allowing a perfect coupling with tubing.The risk is in the acceptable region.No specific action was currently deemed necessary.Livanova will keep monitoring the market.

• Brand Name: DEACONESS MED SPOKANE WA 1
• Common Device Name: SMART, PERFUSION PACKS, CONNECTORS, TUBING
• 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: 16722007
• Report Number: 1718850-2023-00026
• Device Sequence Number: 7293261
• Product Code: DWE
• UDI-Device Identifier: 00803622142437
• UDI-Public: (01)00803622142437(240)044033501(17)240531(10)2213700025
• Combination Product (Y/N): N
• Initial Reporter State: WA
• 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
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 07/04/2023

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: 05/31/2024
• Device Catalogue Number: 044033501
• Device Lot Number: 2213700025
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/14/2023
• Supplement Date Received by Manufacturer: 06/06/2023
• Initial Report FDA Received Date: 04/12/2023
• Supplement Report FDA Received Date: 07/05/2023
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/17/2022
• 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
• Patient Sequence Number: 1
• Patient Sex: Unknown