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

Model Number 2211250099

Device Problem Air/Gas in Device (4062)

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

Event Date 06/26/2023

Event Type  malfunction  

Manufacturer Narrative

A.1.-a.5.There was no patient involvement.D.4.The expiration date refers to the sterile finished product.The complained bcd vanguard is a non sterile component assembled into a convenience pack that is not distributed in the usa.As the sterile convenience pack is not distributed in usa, the udi number is not applicable.H.4.The device manufacture date refers to manufacture date of the sterile, finished convenience pack.H.10.Sorin group italia manufactures the bcd vanguard.The incident occurred in south africa.No external leak was observed.Half of the vanguard filled with air once circulation stoped.The device is available.If any additional information pertinent to the reported event is received, it will be provided in a supplemental report.

Event Description

Sorin group italia has received a report the the air was seen in the top f bcd vanguard during priming for cardioplegia administration.The unit was replaced and the problem was solved.

Manufacturer Narrative

During use, vanguard was connected to heater cooler set at the temperature of 36 degree celsius.No visual evidence showing the phenomenon was provided, consequently unit was requested back for investigation at livanova facility.Involved part was visually inspected and no damage to umbrella valve was noticed.Valve was found to be correctly seated in its housing.A subsequent functional test with water was performed to evaluate potential de-priming of the unit.The fluid reached the air chamber compartment during filling step before the clamp on inlet tubing was released, spillage of water from top side welding area of the air chamber lid was identified.Deep dive inspection of the leaking area at advanced system viewer showed the presence of a crack/fissure as cause of the fluid loss.Laboratory testing in mirandola did not confirm any functional failure of the umbrella valve which was found intact and perfectly seated in its housing.Verification of production records confirmed that noticed lot was released as conform according to specifications.Review of complaints database pointed out no further similar cases notified for batch concerned from the market.Taking into account that customer used the device without reporting any external leakage of fluid which was reproduced at mirandola facility, it is reasonable to suggest that device was integer at customer facility, hence the most likely root cause of claimed phenomenon shall be assigned to accidental misplacement of the umbrella valve during surgery following handling/manipulation of the device.The risk is in the acceptable region.No specific action was currently deemed necessary.Livanova will keep monitoring the market.

Event Description

See intial report.

• Brand Name: BCD VANGUARD PH
• 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: 17387095
• MDR Text Key: 319662419
• Report Number: 9680841-2023-00030
• Device Sequence Number: 1
• Product Code: DTR
• Combination Product (y/n): N
• Reporter Country Code: SF
• PMA/PMN Number: K021830
• 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: 10/25/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/25/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 2211250099
• Device Lot Number: 2211250099
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 09/29/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/23/2022
• 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