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

Catalog Number	044009303
Medical Device Problem Code	Component Misassembled (4004)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/01/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
There issue was identified prior to any patient involvement.Livanova usa inc manufactures the convenience pack.The incident occurred in wilmington, north carolina, united states of america.The involved device is not available for investigation.During follow up with the customer, photographic evidence showing the reported issue were provided by the customer.If any additional information pertinent to the reported event is received, it will be provided in a supplemental report.Device not available.
Event or Problem Description
Livanova inc has received a report that, during set up, it was discovered the yellow and white clamps were swapped.There issue was identified prior to any patient involvement.
Additional Manufacturer Narrative
Livanova received a report stating that at setup the customer noted that the yellow and white clamps on cardioplegia lines were swapped.A clear picture of the swapped lines was provided by the customer confirming the issue.The dhr review highlighted that the complained lot was released conforming to product specifications.A review of the complaints database did not reveal other similar event related to same circuit catalogue item code.Based on the above, the most likely root cause of the reported misassembly was due to a manufacturing operator error during the assembly phase of this circuit.To prevent reoccurrence, the manufacturing personnel has been involved in a dedicated training meeting to discuss the specific event.The risk is in the acceptable region.Livanova will keep monitoring the market.
Event or Problem Description
See initial report.

• 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
• 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: 15091544
• Report Number: 1718850-2022-00047
• Device Sequence Number: 12024025
• Product Code: DWE
• UDI-Device Identifier: 00803622143670
• UDI-Public: (01)00803622143670(240)044009303(17)240430(10)2211800019
• 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
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 09/26/2022

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: 04/30/2024
• Device Catalogue Number: 044009303
• Device Lot Number: 2211800019
• Was Device Available for Evaluation?: No
• 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: 07/01/2022
• Supplement Date Received by Manufacturer: 09/26/2022
• Initial Report FDA Received Date: 07/25/2022
• Supplement Report FDA Received Date: 09/26/2022
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/28/2022
• 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
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown