MAUDE Adverse Event Report: SORIN GROUP ITALIA CSC14 CARDIO.HEAT EXCHANGER N/S; HEAT-EXCHANGER, CARDIOPULMONARY BYPASS,

Model Number 025310

Device Problem Air/Gas in Device (4062)

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

Event Date 10/27/2023

Event Type  malfunction  

Event Description

Sorin group italia has received a report that a significant accumulation of air in the cardioplegia line occurred after about 1.5 minutes from the first blood cardioplegia administration via the ascending aorta to the patient, with an accompanying highpressure alarm.The heat exchanger was one third filled with air.Then, heart-lung machine was immediately stopped by the customer and the arterial system line was inspected: there was no evidence of air.However, following venting and restarting the heart-lung machine, air appeared again in the cardioplegia line, that was flushed through again.Cardioplegia was then administered again without further issues.During further perfusion (without cardioplegia), it was noticeable that blood had collected on the heat exchanger fins.There is no report of patient injury.According to customer evaluation, it cannot be ruled out that patient blood came into contact with the process water of the hypothermia circuit, which is why a supplementary microbiological examination was initiated.

Manufacturer Narrative

A.1.-a.5.Patient information was not provided.D.4.The csc14 blood cardioplegia system is a non-sterile device assembled into a sterile convenience pack (item c22636), lot 2301160095) that is not distributed in the usa.The expiration date refers to the sterile finished product into which the csc14 blood cardioplegia was assembled.As the sterile convenience pack is not distributed in usa, the udi number is not applicable.G.5.The complained csc14 blood cardioplegia is a non-sterile component assembled into a convenience pack that is not distributed in the usa.The stand alone csc14 blood cardioplegia 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 csc was assembled.H.10.Livanova manufactures the csc14 blood cardioplegia.The incident occurred in germany.Through follow-up communication, livanova learned that unit was saved for investigation and pick-up will be arranged.Perfusionist could not attribute the air inflation in the cardioplegia line to a specific cause (a visual inspection was only conducted), nor pictures of the alleged blood to water leakage were taken.Surgery was completed without no known/reported adverse effects.It is not possible to confirm nor deny that the claimed communication between blood and water compartments occurred at customer facility.The involved device has been requested for return to sorin group italia for investigation.If any additional information pertinent to the reported event is obtained, it will be provided in a supplemental report.This report was due on december 02, 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.

Manufacturer Narrative

H10: through follow-up communication with the customer, livanova learned that the unit was discarded, this preventing any functional test to verify the air intake and the alleged communication between blood and water compartments.Review of livanova complaints database identified no other similar issue notified for batch concerned of csc14 from the market.The csc14 device is 100% leak tested before release to market and no event related to sealing issue have been reported in the complaint database in the last three years, out of over 280,000 units sold.According to available information, an unknown origin air ingress occurred in the negative pressure part of the cardioplegia line, before roller pumps.The air was subsequently transferred to the heat exchanger csc14 that is at positive pressure, as also confirmed by the high-pressure alarm triggered by the device monitoring system.The csc14 heat exchanger is equipped with an internal bubble trap to prevent any accidental air in the circuit from overflowing towards the outlet.In case of a large amount of air entering the csc14 and/or potential issues with the sealing of the internal bubble trap, the device can be filled with air that could reach the outlet port.The presence of a hole in the heat exchanger metal sheet can be ruled out as failure mode occurred during the case, since it does not determine any air intake into the device, but rather the passage of blood into the water lines that was not communicated by customer.As explained above, the csc14 operates under positive pressure and cannot be considered as a cause of air ingress by design.The cause of the air ingress remains unknown and it cannot be excluded the it is related to the process followed during the circuit set up at the customer or any other operation.H3 other text : device discarded by customer.

Event Description

See initial report.

• Brand Name: CSC14 CARDIO.HEAT EXCHANGER N/S
• 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 SRL; strada statale 12 nord, 86; mirandola 41037 ; IT 41037
• Manufacturer Contact: enrico greco ; 14401 w. 65th way; arvada, CO 80004
• MDR Report Key: 18334688
• MDR Text Key: 330597809
• Report Number: 9680841-2023-00046
• Device Sequence Number: 1
• Product Code: DTR
• Combination Product (y/n): N
• Reporter Country Code: GM
• 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: 03/13/2024

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 Model Number: 025310
• Device Lot Number: 2212010074
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/15/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 01/16/2023
• 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