MAUDE Adverse Event Report: LIVANOVA USA INC ATRASUMP; SUCKER, CARDIOTOMY RETURN, CARDIOPULMONARY BYPASS

Model Number	SU-XXXXX
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	06/30/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
If any additional information pertinent to the reported event is obtained, it will be provided in a supplemental report.Device not available.
Event or Problem Description
Livanova usa received a report of atrasump tip disconnection during a procedure.There is not report of any patient injury.
Additional Manufacturer Narrative
Livanova received a report stating that, during the procedure, the tip of the su-29602 suction sump cannula came off.No patient was affected.The complained cannula was not made available.However, a clear picture confirming the disconnection between spring inner tubing and connector was provided by the customer.The dhr review highlighted that the complained lot was released conforming to specifications.Review of the livanova complaint database identified in total 4 similar events related to this type of cannula.Based on the investigation of the other similar events, it cannot be ruled out that the root cause of the tip detachment is related to a manufacturing deviation during the assembly phase.To prevent reoccurrence, a capa project was launched.Livanova will keep monitoring the market.
Event or Problem Description
See initial report.
Additional Manufacturer Narrative
In the frame of the capa project, additional investigation of the bond between the connector and tubing has indicated a strength limit related to the adhesive bond between these components due to the design of the connector.To increase the tip to tube pull strength, design changes of the connector are under investigation.The risk remains in the acceptable region.Livanova will keep monitoring the market.Investigation conclusion has been updated accordingly.
Event or Problem Description
See intial report.

• Brand Name: ATRASUMP
• Common Device Name: SUCKER, CARDIOTOMY RETURN, 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: 15091548
• Report Number: 1718850-2022-00048
• Device Sequence Number: 5048439
• Product Code: DTS
• UDI-Device Identifier: 00803622105913
• UDI-Public: (01)00803622105913(240)SU-29602(17)250930(10)2211200064
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• PMA/510(K) Number: EXEMPT
• 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,Followup
• Report Date (Section B): 03/22/2023

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: 04/30/2025
• Device Model Number: SU-XXXXX
• Device Catalogue Number: SU-29602
• Device Lot Number: 2211200064
• 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: 08/30/2022; 02/24/2023
• Initial Report FDA Received Date: 07/25/2022
• Supplement Report FDA Received Date: 09/26/2022; 03/23/2023
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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