MAUDE Adverse Event Report: SORIN GROUP ITALIA REVOLUTION (ASSEMBLED INTO CUSTOMISED PERFUSION TUBING); PUMP, BLOOD, CARDIOPULMONARY BYPASS, NON-ROLLER TYPE

Model Number	REVOLUTION PC
Medical Device Problem Code	Pumping Problem (3016)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/14/2025
Type of Reportable Event	Malfunction
Event or Problem Description
Sorin group italia received a report of a revolution pump which could not provide proper flow when increasing rounds per minutes (rpms), and low pressure was highlighted at inlet pump line.The issue occurred during procedure.There was no patient injury.
Additional Manufacturer Narrative
A.1.-a.5.Patient information was not provided d.4.The revolution pc pump is a non-sterile device assembled into a sterile convenience pack that is distributed in the usa.The unique identifier (udi) and the expiration date refer to the sterile finished product into which the device was assembled.G.5.The involved revolution pc pump is a non-sterile component assembled into a convenience pack that is distributed in the usa.The standalone revolution pc (catalog number 050300700) is also registered in the usa (510(k) number: k190650).H.4.The device manufacturing date refers to manufacturing date of the sterile, finished convenience pack into which the revolution pump was assembled.H11: through follow-up communications, livanova learned that the revolution pump was put at maximum rpms and the target flow was not reached.The pressure/flow issue occurred within one minute after the procedure started.No blood clot was noted in the circuit and no damage was observed on the complained revolution pump.If any additional information pertinent to the reported event is received, it will be provided in a supplemental report.

• Brand Name: REVOLUTION (ASSEMBLED INTO CUSTOMISED PERFUSION TUBING)
• Common Device Name: PUMP, BLOOD, CARDIOPULMONARY BYPASS, NON-ROLLER TYPE
• 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 41037 ; IT 41037
• Manufacturer Contact: annarita di lascio ; 14401 w. 65th way; arvada, CO 80004
• MDR Report Key: 23776508
• Report Number: 9680841-2025-900037
• Device Sequence Number: 9933822
• Product Code: KFM
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K190650
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 05/29/2026

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 Expiration Date: 07/07/2026
• Device Model Number: REVOLUTION PC
• Device Catalogue Number: 436980667 (INTO PTS:046012203)
• Device Lot Number: (PTS: 2523300006)
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/14/2025
• Supplement Date Received by Manufacturer: 05/29/2026
• Initial Report FDA Received Date: 12/11/2025
• Supplement Report FDA Received Date: 05/29/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/21/2025
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown