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	04/11/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Patient information was not provided.At the submission of the case, the customer has provided picture of the atrasump cannulae complained for the disconnection.Complained cannula that detached during use is available and have been requested for investigation.Unit has not been received at livanova facilities.If any additional information pertinent to the reported event is obtained, it will be provided in a supplemental report.
Event or Problem Description
Livanova usa received a report of atrasump tip disconnection during its placement in the heart.There is no report of any patient injury.Additionally, it was reported that in another atrasump cannula belonging to the same item code disconnected from the cannula body during manipulation of the cannula to position in the heart before starting the procedure.The second unit has been disposed by the customer.
Event or Problem Description
See intial 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.Furthermore, it was reported that a second cannula belonging to the same lot had the same issue that occurred before starting the procedure.Thus, in total two units involved.The bloodstained unit, the only one available, was requested for further investigation but was never shipped to livanova arvada.Therefore, the evaluation of the event is based on previous similar events.Review of the livanova complaint database identified in total 4 similar events related to this type of cannula.Inspection of the devices of previous events suggested that the seal at the disconnected part (site between the connector and the tubing) has been done with a thin layer of adhesive.Dimensional analysis of the critical dimensions for this connection were found to be in specification.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 intial 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: 14352258
• Report Number: 1718850-2022-00036
• Device Sequence Number: 4097792
• Product Code: DTS
• UDI-Device Identifier: 00803622105913
• UDI-Public: (01)00803622105913(240)SU-29602(17)241130(10)2133300137
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• 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: 11/30/2024
• Device Model Number: SU-XXXXX
• Device Catalogue Number: SU-29602
• Device Lot Number: 2133300137
• Was Device Available for Evaluation?: Yes
• 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: 04/12/2022
• Supplement Date Received by Manufacturer: 05/20/2022; 02/24/2023
• Initial Report FDA Received Date: 05/11/2022
• Supplement Report FDA Received Date: 06/16/2022; 03/23/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 11/29/2021
• 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