MAUDE Adverse Event Report: LIVANOVA USA INC SUMP; 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	05/03/2023
Type of Reportable Event	Malfunction
Event or Problem Description
Livanova usa inc has received a report that, while using a sump su-29602 cannula in the patient heart, the tip disconnected and had fallen off.There is no report of any patient injury.
Additional Manufacturer Narrative
A.1.-a.5.Patient information were not provided.H.10.Livanova manufactures the sump cannula.The incident occurred in united states.A clear photographic evidence was provided at the submission of case.If any additional information pertinent to the reported event is received, it will be provided in a supplemental report.
Additional Manufacturer Narrative
The dhr review confirmed the device was released conforming to product specifications.Review of the livanova complaint database, identified that other similar complaints were recorded from different customers but on different cannula lots in the last year.Investigation suggested the root cause of the reported issue is suboptimal interference between the tip and cannula body.Livanova has launched a capa to identify adequate corrective actions.The risk is in the acceptable region.No specific action was currently deemed necessary.Livanova will keep monitoring the market.
Event or Problem Description
See intial report.

• Brand Name: SUMP
• 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: 17038522
• Report Number: 1718850-2023-00031
• Device Sequence Number: 20461979
• Product Code: DTS
• UDI-Device Identifier: 00803622105913
• UDI-Public: (01)00803622105913(17)250430(10)2211700001(11)220429(240)SU-29602
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• 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
• Report Date (Section B): 08/24/2023

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: 2211700001
• 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: 05/05/2023
• Supplement Date Received by Manufacturer: 07/26/2023
• Initial Report FDA Received Date: 06/01/2023
• Supplement Report FDA Received Date: 08/24/2023
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/17/2022
• 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