MAUDE Adverse Event Report: SORIN GROUP ITALIA SRL SMARXT BCD VANGUARD SYSTEM; HEAT-EXCHANGER, CARDIOPULMONARY BYPASS

Catalog Number 050229

Device Problem Use of Device Problem (1670)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 09/07/2022

Event Type  malfunction  

Event Description

Sorin group italia has received a report that, after priming and venting with blood, air was accumulated in the top of the bcd vanguard cardioplegia heat exchanger.Medical team verified the circuit again and tightened connections.After that, air bubbles kept accumulating in the bcd vanguard cardioplegia heat exchanger.Medical team elected to change-out the entire cardioplegia kit.There is no report of any patient injury.

Manufacturer Narrative

The bcd vanguard cardioplegia heat exchanger is a non-sterile device assembled into a sterile convenience pack (item c22577, lot 2206100150) that is not distributed in the usa.The expiration date refers to the sterile finished product into which the oxygenator was assembled.As the sterile convenience pack is not distributed in usa, the udi number is not applicable.The complained bcd vanguard cardioplegia heat exchanger is a non-sterile component assembled into a convenience pack that is not distributed in the usa.The device manufacture date refers to manufacture date of the sterile, finished convenience pack into which the oxygenator was assembled.Sorin group italia manufactures the bcd vanguard cardioplegia heat exchanger.The incident occurred in amsterdam, netherland (the).The involved device is available and has not been requested.If any additional information pertinent to the reported event is obtained, it will be provided in a supplemental report.

Manufacturer Narrative

Livanova received a report that air accumulated in the top of the bcd vanguard.No patient/user affected.No pictures or video showing the defect were provided, visual inspection of returned bcd vanguard highlighted the presence of a crack across the top welding area of air chamber compartment.During the leak test, a leak could be observed from the above-described crack.Since the unit was returned with a crack (no mechanical integrity) no functional test to verify the claimed issue (air intake) could be performed.Verification of manufacturing records confirmed the device was released conforming to product specifications.Review of livanova complaints did not identify any other event relevant to the complained lot thus excluding a systematic issue.Accordingly, no trend for this kind of failure is observed.Follow up with the customer did not confirm any external leak but air ingress in the device.Therefore, the most probable root cause of the crack was an accidental impact/rough handling of the device.Since no functional test could be performed, a deviation of the device umbrella valve (causing air intake) could not be excluded.The risk is in the acceptable region.No action is deemed necessary.Livanova will keep monitoring the market.

Event Description

See intial report.

• Brand Name: SMARXT BCD VANGUARD SYSTEM
• Type of Device: HEAT-EXCHANGER, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): SORIN GROUP ITALIA SRL; strada statale 12 nord, 86; mirandola 41037
• Manufacturer (Section G): SORIN GROUP ITALIA SRL; strada statale 12 nord, 86; mirandola 41037 ; IT 41037
• Manufacturer Contact: enrico greco ; 14401 w 65th way; arvada, CO 80004
• MDR Report Key: 15549154
• MDR Text Key: 306883741
• Report Number: 9680841-2022-00044
• Device Sequence Number: 1
• Product Code: DTR
• Combination Product (y/n): N
• Reporter Country Code: NL
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Other
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 01/19/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/06/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 050229
• Device Lot Number: 2205020083
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 01/22/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/10/2022
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1