MAUDE Adverse Event Report: SORIN GROUP ITALIA CSC14 CARDIOPLEGIA 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 07/28/2023

Event Type  malfunction  

Manufacturer Narrative

A.1.-a.5.Patient information was not provided d.4.The csc14 cardioplegia heat exchanger is a non-sterile device assembled into a sterile convenience pack (item ab3765) that is not distributed in the usa.The expiration date refers to the sterile finished product into which the csc14 cardioplegia heat exchanger was assembled.As the sterile convenience pack is not distributed in usa, the udi number is not applicable.G.5.The complained csc14 cardioplegia heat exchanger is a non-sterile component assembled into a convenience pack that is not distributed in the usa.The stand alone csc14 cardioplegia heat exchanger 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 csc14 cardioplegia heat exchanger was assembled.H.10.Livanova manufactures the csc14 cardioplegia heat exchanger.The incident occurred in united kingdom.As per follow up with the customer, no vacuum assistance device is used for this case.The leak was coming from the csc cartridge and had not entered via the connection between the purge line and reservoir.The leak was coming from the bottom of the csc cartridge itself.The leak might have gone unnoticed due to condensation (heater cooler water lines were connected and running at 2 degrees).No air intake was noted when the cardioplegia was running.It initially happened after cardioplegia delivery was complete and the root vent was on.The 2nd time it de-primed was after cardioplegia delivery and the root vent was off.The drip was noted after this stage and it continued to drip blood throughout the case.As per livanova initial considerations, the entry of air is unlikely to come from where the blood is leaking (drop).The air may have entered from the top of the circuit, in particular from the recirculation line due to a negative pressure on reservoir (venous side).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.

Event Description

Soring group italia has received a report that, during a procedure, after administering the cardioplegia, the csc 14 cardioplegia heat exchanger intook air.The csc 14 cardioplegia heat exchanger was primed again and intook air again blood leak was seen from the corner of the csc 14 cardioplegia heat exchanger.Team believe air is entering through this point.The csc 14 cardioplegia heat exchanger was not changed and the procedure was completed by applyin bone wax to the leaking point.The leak did not stop.There is no report of any patient injury.

Manufacturer Narrative

H10: visual inspection of returned csc14 cardioplegia heat exchanger highlighted the presence of dried blood traces at the bottom right corner of the device.The purge line was not returned.The blood compartment of the returned csc14 cardioplegia heat exchanger device was filled with methylene blue and gradually pressurized up to 1 bar (maximum pressure value permitted in blood compartment) for 1 hour, by sealing all the outlet ports and connecting a pressure gauge to the circuit to monitor the internal pressure.When the pressure in the blood compartment reached 0.9 bar, leakage was observed in the bottom of the unit.No air intake (depriming) in the returned csc14 cardioplegia heat exchanger was observed during the whole test.Review of livanova complaints database pointed out no other similar issues notified for batch concerned from the market.The root cause of the complained leak is an inadequate penetration of the resin in the bottom metal sheet likely associated to excess of compaction between the coils in assembly line and/or non-conforming dispensing of the resin by dedicated tool in manufacturing area.This type of issue is not detectable during the manufacturing leak test.Accordingly, the unit has positively passed all in-house leak test.To reduce further recurrences, in may 2022, livanova implemented an improvement of resin dispenser tool.The complained unit was manufactured after above process optimization.However, the trend has improved.This kind of leak is minimal and does not cause any patient detriment.The cardioplegia circuit can be substituted any time without any patient impact.Therefore, the event has unlikely possibility to cause any patient injury.The event is being reassessed as not reportable.

Event Description

See initial report.

• Brand Name: CSC14 CARDIOPLEGIA 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: 17622956
• MDR Text Key: 321935703
• Report Number: 9680841-2023-00035
• Device Sequence Number: 1
• Product Code: DTR
• Combination Product (y/n): N
• Reporter Country Code: UK
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Reporter Occupation: Other
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 07/28/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/25/2023
• 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: 2210270063
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/05/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/01/2022
• 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