MAUDE Adverse Event Report: LIVANOVA USA INSTITUTE DE CARDIOLOGIE1; TUBING, PUMP, CARDIOPULMONAY BYPASS

Model Number	627230202
Medical Device Problem Code	Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/21/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A.1.-a.5.Patient information was not provided.H.11.Livanova usa manufactures the customized circuit.Pump was primed normally at 36 degrees with plasmalyte solution no liquid leakage into the pump head ecc was initial with arterial temperature 33 degrees.Blood loss 200cc.Patient did not show problem the next day.The pump in use was not a livanova device and there is no information if the machine has been checked by a field service technician.However, over-occlusion of the pump was excluded as root cause no initial defect was observed on the tubing it was not clarified whether the patient was in beating phase when event occurred.If any additional information pertinent to the reported event is received, it will be provided in a supplemental report.
Event or Problem Description
Livanova usa received a report that, during a procedure, blood leak was oberved by the pumphead and pump outlet.Medical team elected to stop the ecc, change the raceway and prime an new arterial pump.Pporcedure was completed with no issue.There is no report of any patient injury.
Additional Manufacturer Narrative
Visual inspection of the provided photos confirmed the split in the tubing.The complained tubing was never returned for investigation.Based on the review of the livanova database, no other similar complaints has been recorded neither for this customized circuit, nor for this specific tubing lot.No concerning trend has been detected for this kind of failure.It cannot be excluded that an initial defect in the tubing, such as a cut or puncture, was present and went undetected and propagated during use under compression in the roller pump.No definitive conclusion can be drawn on the root cause of the defect and on when it may have been caused, either at manufacturing or at customer's site.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 initial report.

• Brand Name: INSTITUTE DE CARDIOLOGIE1
• Common Device Name: TUBING, PUMP, CARDIOPULMONAY BYPASS
• Manufacturer (Section D): LIVANOVA USA; 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: 20244137
• Report Number: 1718850-2024-00037
• Device Sequence Number: 15282080
• Product Code: DWE
• UDI-Device Identifier: 00803622114823
• UDI-Public: (01)00803622114823(240)627230202(17)260612(10)2416400021(11)240612
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K981613
• 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): 01/20/2025

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: 06/12/2026
• Device Model Number: 627230202
• Device Lot Number: 2416400021
• 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: 08/21/2024
• Supplement Date Received by Manufacturer: 12/23/2024
• Initial Report FDA Received Date: 09/18/2024
• Supplement Report FDA Received Date: 01/21/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/12/2024
• 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: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown