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

Catalog Number 050229

Device Problem Air/Gas in Device (4062)

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

Event Date 10/30/2023

Event Type  malfunction  

Manufacturer Narrative

D.4.The complained bcd vanguard 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 bcd vanguard was assembled.G.5.The product item 050228j is not distributed in the usa, but it is similar to the bcd vanguard item 050228, which is distributed in the usa (510(k) number: k021830).H.4.The device manufacture date refers to manufacture date of the sterile, finished convenience pack into which the bcd vanguard was assembled.H.10.Sorin group italia manufactures the bcd vanguard.The incident occurred in usa.Follow up with the customer clarified that: the line was clamped post heat-enchanger.The pressure would have maybe been a positive 30ish.When priming,a small amount of plasmalyte pulsing with the roller head escaping the valve was visible.If any additional information pertinent to the reported event is received, it will be provided in a supplemental report.This report was due on november 29, 2023; however, due to a network disruption at livanova, the ability to submit mdrs was lost on november 19, 2023, before this report was ready to submit.The report was prepared and submitted immediately following restoration of the livanova systems.

Event Description

Sorin group italia has received a report that, while priming the circuit and deairing the heat exchanger, medical team noticed that air was being entrained through the one way valve on the top of the vanguard heat exchanger (when under negative pressure).They noticed positive pressure caused it to leak fluid out of the one way valve on top while the cardioplegia roller pump was causing it to pulse.There was no patient involvement.

Manufacturer Narrative

Involved device was requested back for investigation at livanova facility.Visual inspection of returned part revealed no sign of damage to the umbrella valve and its housing.No pinched nor misplaced portion was detected.A subsequent functional dye leak test on the blood side was carried out to verify the behavior of the umbrella valve.The device was filled with methylene blue and gradually pressurized up to 1 bar (maximum pressure value permitted in blood compartment), by sealing all the outlet ports and connecting a pressure gauge to the circuit to monitor the internal pressure.When the fluid reached the air chamber compartment, the hydrophobic membrane turned blue-colored and blue drops mixed with bubbles leaked out from the umbrella valve.A passage of liquid through the hydrophobic membrane was reproduced, indicating the complete loss of the water repelling property.Involved material is externally supplied.Consequently, reported event has been traced back to isolated supplier deviation.As for the complained air ingress, it shall be emphasized that the bcd vanguard is a device developed to always work with positive pressure.In this case, the air intake occurred under the application of negative pressure to the device.Therefore, based on the above findings, it can be concluded that reported unconventional testing conditions allowed the generation of air inside the device, possibly enhanced by the observed damage to the hydrophobic membrane.No depriming was confirmed accordingly (user error led to the ingress of air in the unit).No adverse trend was identified for this type of issue from market rate analysis.Livanova maintains and documents periodic customer events monitoring process in order to evaluate actions for products improvement.The risk is in the acceptable region.No specific action was currently deemed necessary.Livanova will keep monitoring the market.

Event Description

See initial report.

• Brand Name: SMARXT BCD VANGUARD SURFACE MODIFIED CARDIOPLEGIA SYSTEM
• Type of Device: HEAT-EXCHANGER, CARDIOPULMONARY BYPASS,
• Manufacturer (Section D): SORIN GROUP ITALIA; strada statale 12 nord, 86; mirandola
• Manufacturer (Section G): SORIN GROUP ITALIA; strada statale 12 nord, 86; mirandola 41037 ; IT 41037
• Manufacturer Contact: enrico greco ; 14401 w 65th way; arvada, CO 80004
• MDR Report Key: 18334570
• MDR Text Key: 330596775
• Report Number: 9680841-2023-00045
• Device Sequence Number: 1
• Product Code: DTR
• UDI-Device Identifier: 00803622154188
• UDI-Public: (01)00803622154188(240)065266300(17)240907(10)2325100028(11)230908
• Combination Product (y/n): N
• Reporter Country Code: US
• 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: 04/23/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/15/2023
• 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: 2305240130
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/26/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/07/2023
• 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