MAUDE Adverse Event Report: LIVANOVA USA SMART, PERFUSION PACKS; TUBING, PUMP, CARDIOPULMONARY BYPASS

Catalog Number	627356101
Medical Device Problem Code	Disconnection (1171)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/10/2024
Type of Reportable Event	Malfunction
Event or Problem Description
Livanova usa inc received a report that the connection of stopcock/shunt line in custom pack broke while patient was on ecmo support.There is no report of any patient injury-.
Additional Manufacturer Narrative
A.1.-a.5.Patient information were not provided.H.10.Livanova usa manufactures the smart perfusion packs.The incident occurred in usa.As per the clinician¿s account, air entered in the circuit due to the broken connection and there is no confirmation of air reaching the patient.The circuit was change out.The part that disconnected is the shunt line that connects the post-oxygenator arterial limb of the ecmo circuit to the pre-pump venous limb of the circuit.This part of the circuit is connected to the venous (negative pressure) limb of the circuit.Perfusionist was able to immediately troubleshoot to minimize potential patient impact.If any additional information pertinent to the reported event is received, it will be provided in a supplemental report.
Event or Problem Description
See initial report.
Additional Manufacturer Narrative
H11: pictures of the issue were provided by the customer as evidence, confirming that involved connector had broken from its ring, that stayed connected to the stopcock.As per perfusion tubing system (pts) drawing (catalogue number 627356101, revision e), the connector in the shunt line is internally bonded to a tubing with solvent and then twist-connected to the stopcock.This shunt line connects the post-oxygenator arterial limb of the ecmo circuit to the pre-pump venous limb of the circuit via luer connections.Sample was not available for investigation.A review of the complaints database revealed that no further similar events occurred on this pts lot nor pts catalogue number, neither a concerning trend has been identified.Based on the available information and without the possibility to investigate the components, it cannot be ruled out that reported breakage could have been due to a fragility of the connector, that could have accidentally got damaged as a result of rough handling and transportation stresses occurred during product delivery to customer, that were enhanced during procedure.It cannot be ruled out also that an excess of solvent used during bonding in manufacturing could have contributed to damaging the tubing and its connection, however this could not be confirmed.

• Brand Name: SMART, PERFUSION PACKS
• Common Device Name: TUBING, PUMP, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): LIVANOVA USA; 14401 w 65th way; arvada 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: 19268505
• Report Number: 1718850-2024-00030
• Device Sequence Number: 12507892
• Product Code: DWE
• UDI-Device Identifier: 00803622131479
• UDI-Public: (01)00803622131479(240)627356101(17)250710(10)2319200040(11)230711
• Combination Product (Y/N): N
• Initial Reporter State: OR
• 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
• Initial Reporter Occupation: Other
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 11/25/2024

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: 07/10/2025
• Device Catalogue Number: 627356101
• Device Lot Number: 2319200040
• 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: 04/10/2024
• Supplement Date Received by Manufacturer: 10/28/2024
• Initial Report FDA Received Date: 05/08/2024
• Supplement Report FDA Received Date: 11/25/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/10/2023
• 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