MAUDE Adverse Event Report: LIVANOVA USA SMART, PERFUSION PACKS, CONNECTORS, TUBING; TUBING, PUMP, CARDIPULMONARY

Model Number	025310
Medical Device Problem Code	Misassembled (1398)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/12/2023
Type of Reportable Event	Malfunction
Event or Problem Description
Livanova usa inc received a report that the cardioplegia lines in the cardioplegia circuit were reversed.The issue was identified during bypass.Medical team elcted to adiminister additional cardioplegia dose.There is no report of any patient injury.
Additional Manufacturer Narrative
A.1.-a.5.No patient information has been provided.D.4.The cardioplegia heat exchanger csc14 is a non-sterile device assembled into a sterile convenience pack that is distributed in the usa.The expiration date refers to the sterile finished product into which the oxygenator was assembled.The unique identifier (udi) number of the sterile convenience pack is (b)(4).G.5.The involved cardioplegia heat exchanger csc14 is a non-sterile component assembled into a convenience pack that is distributed in the usa.The csc14 is registered in the usa (510(k) number: k012898).H.4.The device manufacture date refers to manufacture date of the sterile, finished convenience pack into which the oxygenator was assembled.H.10.Livanova manufactures the cardioplegia heat exchanger csc14.The incident occurred in united states.Livanova learned that medical team elected toadminister an additional dose because the patient was not staying arrested on the initial delivery.That is when they investigated and noticed the lines were reversed.Customer has used other packs from this lot and the cardioplegia lines were not mixed, so it appears this was an isolated incident and not the entire lot.Delivery of additional doses of cardioplegia is part of the protocol.If the heart is not totally arrested the hcp might change the site of delivery or change the type and it is also expected and can be consider part of the procedure.If any additional information pertinent to the reported event is received, it will be provided in a supplemental report.
Additional Manufacturer Narrative
During a the preparation of the follow up, it was indentified the mfr report number 1718850-2023-00034 was incorrectly sent metioning the csc14 heater exchanger.However, the issue is not related to the heat exchanger and is related to the circuit assembly.The following fields have been corrected.A clear picture of the misassembly was provided by the customer, confirming the issue.The dhr review highlighted that the involved lot was released as conform according to specifications.A review of the complaints database did not reveal further similar events occurred on this pts pack code or concerned batch.Customer confirmed that this was an isolated event.Based on the above, the most likely root cause of the reported event was a manufacturing operator error during the assembly phase of this pts.The personnel will be involved in a dedicated training meeting awaring of customer complaint.The likelihood of occurrence of the failure is in line with what documented and accepted in the relevant risk management file.The risk is in the acceptable region.
Event or Problem Description
See initial report.

• Brand Name: SMART, PERFUSION PACKS, CONNECTORS, TUBING
• Common Device Name: TUBING, PUMP, CARDIPULMONARY
• 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: 17434700
• Report Number: 1718850-2023-00034
• Device Sequence Number: 7405701
• Product Code: DWE
• UDI-Device Identifier: 00803622148255
• UDI-Public: (01)00803622148255(240)046007401(17)250604(10)2315600044(11)230605
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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
• Type of Report: Initial,Followup
• Report Date (Section B): 10/10/2023
• 2 Devices were Involved in the Event: 1 2

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: 06/04/2025
• Device Model Number: 025310
• Device Catalogue Number: 046007401
• Device Lot Number: 2315600044
• 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: 07/13/2023
• Supplement Date Received by Manufacturer: 10/09/2023
• Initial Report FDA Received Date: 08/01/2023
• Supplement Report FDA Received Date: 10/10/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/05/2023
• 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
• Patient Sequence Number: 1
• Patient Sex: Unknown