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

Catalog Number	627165604
Medical Device Problem Code	Misassembled (1398)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/02/2022
Type of Reportable Event	Malfunction
Event or Problem Description
Livanova usa inc has been informed that, during the setup of the circuit, the medical team identified that white and yellow clamps of the cardioplegia circuit were swapped with the respect to the technical drawing.There is no patient involvement.
Additional Manufacturer Narrative
There was no patient involvement.Livanova usa inc manufactures the convenience pack adult perfusion circuit (b)(6).The incident occurred in (b)(6), united states.The involved device has is not available for investigation.If any additional information pertinent to the reported event is received, it will be provided in a supplemental report.
Additional Manufacturer Narrative
Livanova received a report stating that the yellow and white clamps along the cardioplegia linewere not in the correct positions.At the submission of the case, an exhaustive photo was provided as evidence of the defect found by the customer.Therefore the event is confirmed.The dhr of the complained lot review highlighted that the lot was released as conform according to specifications.No similar events were recorded by the customer, thus suggesting this is an isolated case.Based on the above, livanova believes the most probable root cause of the reported issue was traced back to an isolated operator error during the manufacturing assembly phase.The personnel will be involved in a dedicated training meeting a waring of customer complaint.The risk is in the acceptable region.Livanova will keep monitoring the market for similar events h3 other text: picture available.

• Brand Name: COBE 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: 13665458
• Report Number: 1718850-2022-00024
• Device Sequence Number: 4996354
• Product Code: DWE
• UDI-Device Identifier: 00803622106965
• UDI-Public: (01)00803622106965(240)627165604(17)240131(10)2200400154
• 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): 05/02/2022

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: 01/31/2024
• Device Catalogue Number: 627165604
• Device Lot Number: 2200400154
• 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: 02/02/2022
• Supplement Date Received by Manufacturer: 04/02/2022
• Initial Report FDA Received Date: 03/04/2022
• Supplement Report FDA Received Date: 05/03/2022
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/04/2022
• 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