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

Model Number	SU-XXXXX
Medical Device Problem Code	Disconnection (1171)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/21/2021
Type of Reportable Event	Malfunction
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
Patient information was not provided.Pma/510k: exempt.At the submission of the case, the customer has provided picture of the disconnected atrasump.The units were requested for deep investigation.Initial visual inspection of the provided picture suggested the transition bond was not performed for this unit.First piece inspection and qc sampling have did not identify any other similar issue.Retraining for employees involved with the build and inspection of the transition bond step has been performed.If any additional information pertinent to the reported event is obtained, it will be provided in a supplemental report.Not yet received.
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
Patient information was not provided.Pma/510k: exempt.At the submission of the case, the customer has provided picture of the disconnected atrasump.The units were requested for deep investigation.Initial visual inspection of the provided picture suggested the transition bond was not performed for this unit.First piece inspection and qc sampling have did not identify any other similar issue.Retraining for employees involved with the build and inspection of the transition bond step has been performed.If any additional information pertinent to the reported event is obtained, it will be provided in a supplemental report.Not yet received.
Additional Manufacturer Narrative
According to follow up information with the customer, other 2 cannula units belonging to the same lot were manually tested by not forcefully pulling the tip and the customer reported the tip came off as if it was not ¿welded¿ to the rest of the cannula.The seven (7) unused remaining units have been received at sorin italia.
Event or Problem Description
See initial report.
Additional Manufacturer Narrative
The complained cannula has been received at livanova usa inc facilities and is under investigation.If any additional information pertinent to the reported event is obtained, it will be provided in a supplemental report.
Event or Problem Description
See initial report.
Event or Problem Description
See initial report.
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 dhr review highlighted that the complained lot was released conforming to specifications.The unit has been requested for investigation and received in arvada site along with other 8 not-used units.Inspection of the disconnected part (site between the connector and the tubing) and of all the other returned units suggested that the seal has been done with a thin layer of adhesive.Dimensional analysis of the critical dimensions for this connection were found to be in specification.Review of the livanova complaint database identified in total 4 similar events related to this type of cannula.Based on livanova investigation, 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.

• 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: 12809044
• Report Number: 1718850-2021-00050
• Device Sequence Number: 5120286
• Product Code: DTS
• UDI-Device Identifier: 00803622105913
• UDI-Public: (01)00803622105913(240)SU-29602(17)240831(10)2123500110
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• 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,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: 08/31/2024
• Device Model Number: SU-XXXXX
• Device Catalogue Number: SU-29602
• Device Lot Number: 2123500110
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/02/2021
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/21/2021
• Supplement Date Received by Manufacturer: 11/18/2021; 02/04/2022; 05/19/2022; 02/24/2023
• Initial Report FDA Received Date: 11/15/2021
• Supplement Report FDA Received Date: 12/15/2021; 02/24/2022; 06/16/2022; 03/23/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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