MAUDE Adverse Event Report: LIVANOVA USA INC SMART CARDIOPLEGIA; SMART, PERFUSION PACKS, CONNECTORS, TUBING

Catalog Number	627193402
Medical Device Problem Code	Component Misassembled (4004)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Event or Problem Description
Livanova usa inc has received a report that the position of the clamp colors in the cardioplegia kit being used were incorrect when compared with the pack specification sheet.In details, both red clamps were on the small tubing side and both white clamps are on the large tubing side.According to the perfusionist, as a consequence, the content of a bag of high potassium (k) was delivered into the reservoir despite having both white clamps closed.This occurred prior to the cardiopulmonary bypass, so it had no impact on the patient.There is not report of any patient injury.
Additional Manufacturer Narrative
There was no patient involvement.Event date is unknown.The device was disposed by the customer.Livanova usa manufactures the smart cardioplegia.The incident occurred in (b)(6) united states of america.The device was disposed by the customer.However, a photographic evidence confirming the misassembly was provided by the customer.If any additional information pertinent to the reported event is received, it will be provided in a supplemental report.Disposed by the customer.
Additional Manufacturer Narrative
Livanova received a report stating that during setup, the customer noted that the positions of colored clamps on the cardioplegia kit were incorrect.The result of this incorrect position of the clamp colors was the draining of a bag of high k into the reservoir.This occurred prior to the cardiopulmonary by-pass, therefore it had no impact on the patient.A clear picture of the misassembly was provided by the customer, confirming the issue.Sample was not available because it was thrown away after the case.The dhr review highlighted that the lot whose claimed product belong to was released as conform according to specifications.For this pts pack code is not foreseen a 100% inspection.A review of the complaints database did not reveal further similar event occurred on this pts pack code or concerned batch.Based on the above facts, most likely root cause of the reported event was due to manufacturing operator error during the assembly phase of this pts.The manufacturing personnel will be involved in a dedicated training meeting to discuss the customer complaint.The risk is in the acceptable region.No other corrective action is deemed necessary.Livanova will keep monitoring the market.
Event or Problem Description
See initial report.

• Brand Name: SMART CARDIOPLEGIA
• Common Device Name: SMART, PERFUSION PACKS, CONNECTORS, TUBING
• 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: 15549153
• Report Number: 1718850-2022-00053
• Device Sequence Number: 1995986
• Product Code: DWE
• UDI-Device Identifier: 00803622147425
• UDI-Public: (01)00803622147425(240)627193402(17)230430(10)2218600038
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• 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): 12/01/2022

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: 04/30/2023
• Device Catalogue Number: 627193402
• Device Lot Number: 2218600038
• 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: 09/07/2022
• Supplement Date Received by Manufacturer: 11/05/2022
• Initial Report FDA Received Date: 10/06/2022
• Supplement Report FDA Received Date: 12/02/2022
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/05/2022
• 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