MAUDE Adverse Event Report: SORIN GROUP ITALIA VANGUARD; RESERVOIR, BLOOD, CARDIOPULMONARY BYPASS

Model Number	BCD VANGUARD PC COATED NS
Medical Device Problem Code	Defective Component (2292)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/19/2026
Type of Reportable Event	Malfunction
Event or Problem Description
Sorin group italia received a report of a vanguard which started de-prime after concluding the device priming phase.The unit was replaced with a new one.There was no patient involvement.
Additional Manufacturer Narrative
A1-a5: there was no patient involvement.D4: the complained bcd vanguard is a non-sterile component assembled into a sterile pack sold in us.The sterile product is currently unknown, and will be provided with its udi in a supplemental report if made available.H4: as the serial number of sterile product is unknown, the device manufacture date could not be determined.This information will be provided in a supplemental report if made available.H11: livanova initiated an investigation.If any additional information pertinent to the reported event is received, it will be provided in a supplemental report.

• Brand Name: VANGUARD
• Common Device Name: RESERVOIR, BLOOD, 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: 24361970
• Report Number: 9680841-2026-900005
• Device Sequence Number: 20100360
• Product Code: DTN
• UDI-Device Identifier: 00803622136986
• UDI-Public: (01)00803622136986(17)271202(11)251202(240)627385401(10)2533600049
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K934847
• 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): 06/12/2026

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 Model Number: BCD VANGUARD PC COATED NS
• Device Catalogue Number: 050229(ASSEMBL.INTO 627385401)
• Device Lot Number: 2510160053 (INTO 2533600049)
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/20/2026
• Supplement Date Received by Manufacturer: 05/15/2026
• Initial Report FDA Received Date: 02/17/2026
• Supplement Report FDA Received Date: 06/12/2026
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown