MAUDE Adverse Event Report: SORIN GROUP ITALIA CSC14 CARDIOPLEGIA HEAT EXCHANGER; HEAT-EXCHANGER, CARDIOPULMONARY BYPASS

Model Number	CSC14 CARDIO.HEAT EXCHANGER N/S
Medical Device Problem Code	Device Contaminated During Manufacture or Shipping (2969)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/14/2025
Type of Reportable Event	Malfunction
Event or Problem Description
Sorin group italia received a report that, during priming,plastic particles were seen floating within the heath exchanger csc14.There is no report of any patient injury.
Additional Manufacturer Narrative
A1_a5 patient information was not provided.H11 sorin group italia is the manufacturer for csc14, the event has occurred in the united states.Complained device has returned to the manufacturing site for investigation.Visual inspection could not locate any particle inside the unit.Then, elution test was performed: bubbles generated were retained within the bubble trap and expelled through the purge port, with no plastic fragments detected.Based on product analysis, the presence of any foreign object within the device was not confirmed.Analysis of complaints database revealed no other similar occurrences notified for batches concerned (csc14 and pts) from the market, thus excluding any systematic quality deviation batch-related.Based on investigation findings, the following scenarios cannot be excluded: - the particle may have been lost during return shipment to livanova, as the purge port was not sealed.- the particle may have been introduced and remained undetected during csc14 manufacturing or pts assembly.- the particle may have originated from crystallization of salts in the priming solution, which later dissolved during testing or over time.The risk is in the acceptable region.No specific action was currently deemed necessary.Livanova will keep monitoring the market.

• Brand Name: CSC14 CARDIOPLEGIA HEAT EXCHANGER
• Common Device Name: HEAT-EXCHANGER, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): SORIN GROUP ITALIA; via statale 12 nord, 86; mirandola (mo) 41037 ; IT 41037
• Manufacturer (Section G): SORIN GROUP ITALIA; via statale 12 nord, 86; mirandola (mo) 41037 ; IT 41037
• Manufacturer Contact: annarita di lascio ; 14401 w. 65th way; arvada, CO 80004
• MDR Report Key: 23838005
• Report Number: 9680841-2025-900041
• Device Sequence Number: 21149158
• Product Code: DTR
• UDI-Device Identifier: 00803622155260
• UDI-Public: (01)00803622155260(17)270102(11)250102(240)627383702(10)2500200085
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K012898
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 12/18/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: CSC14 CARDIO.HEAT EXCHANGER N/S
• Device Catalogue Number: 025310 (IN 627383702)
• Device Lot Number: 2411060127 (IN 2500200085)
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/25/2025
• Initial Report FDA Received Date: 12/18/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/02/2025
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: A
• Patient Sequence Number: 1
• Patient Sex: Unknown