MAUDE Adverse Event Report: LIVANOVA USA INC CARDIOPLEGIA ADAPTERS, VESSEL CANULAE, AND AORTIC ROOT CANNULAE; CATHETER, CANNULA AND TUBING, VASCULAR, CARDIOPULMONARY BYPASS

Model Number	AR-XXXXX
Medical Device Problem Code	Disconnection (1171)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/04/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Patient information was not provided.A review of the dhr did not identify any deviations or non-conformities relevant to the reported issue.The involved device is not available for investigation.Livanova believes the most probable root cause of the disconnection is ascribable to a human error during manufacturing of the unit.The manufacturing personal has been re-trained on the issue.However, without the possibility to inspect the unit, the root cause could not be confirmed.
Event or Problem Description
Livanova usa inc has been informed that, during a procedure, the plastic tip comes off from the metal part of the catheter.There is not report of any patient injury.
Event or Problem Description
See initial report.
Additional Manufacturer Narrative
Neither the complained unit nor any photographic evidence was provided by the customer.Dhr review has not pointed out any deviations or non-conformities possibly relevant to occurred issue and no further similar complaints have been recorded for noticed product lot.This is a known issue for which livanova completed a capa.This appears to be the first failing unit manufactured after the implementation of the corrective actions.Livanova believes the most probable root cause of the disconnection is ascribable to a human error during manufacturing of the unit.The manufacturing personal has been re-trained on the issue.However, without the possibility to inspect the unit, the root cause could not be confirmed.The risk is acceptable.No other corrective action is deemed necessary.

• Brand Name: CARDIOPLEGIA ADAPTERS, VESSEL CANULAE, AND AORTIC ROOT CANNULAE
• Common Device Name: CATHETER, CANNULA AND TUBING, VASCULAR, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): LIVANOVA USA INC; 14401 w 65th way; arvada CO 80004
• MDR Report Key: 11899593
• Report Number: 1718850-2021-00032
• Device Sequence Number: 16488055
• Product Code: DWF
• UDI-Device Identifier: 00803622103001
• UDI-Public: (01)00803622103001(240)AR-11012(17)231231(10)2035000005
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K972503
• 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): 07/30/2021

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: 12/31/2023
• Device Model Number: AR-XXXXX
• Device Catalogue Number: AR-11012
• Device Lot Number: 2035000005
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 05/04/2021
• Supplement Date Received by Manufacturer: 07/01/2021
• Initial Report FDA Received Date: 05/28/2021
• Supplement Report FDA Received Date: 07/30/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1