MAUDE Adverse Event Report: VANTIVE US HEALTHCARE LLC CARTRIDGE BLOOD SET; SET, TUBING, BLOOD, WITH AND WITHOUT ANTI-REGURGITATION VALVE

Catalog Number	101025
Medical Device Problem Codes	Break (1069); Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/04/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Should additional relevant information become available, a supplemental report will be submitted.
Event or Problem Description
It was reported that an external fluid leak was observed from the broken cassette of a gambro cartridge line during priming.There was no patient involvement.No additional information is available.

• Brand Name: CARTRIDGE BLOOD SET
• Common Device Name: SET, TUBING, BLOOD, WITH AND WITHOUT ANTI-REGURGITATION VALVE
• Manufacturer (Section D): VANTIVE US HEALTHCARE LLC; deerfield IL
• Manufacturer (Section G): VANTIVE HEALTHCARE - TIJUANA BAJA; blvd. pacifico 10014; parque industrial pacifico; tijuana baja california CP 22 643; MX CP 22643
• Manufacturer Contact: 510 lake cook rd; deerfield, il, IL 60015 ; 8153072966
• MDR Report Key: 25101375
• Report Number: 8030638-2026-00002
• Device Sequence Number: 10018721
• Product Code: FJK
• UDI-Device Identifier: 07332414007836
• UDI-Public: 7332414007836
• Combination Product (Y/N): N
• Initial Reporter Country: CO
• PMA/510(K) Number: K070414
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 06/04/2026

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 Catalogue Number: 101025
• Device Lot Number: MA0125224176
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/15/2026
• Supplement Date Received by Manufacturer: 06/03/2026
• Initial Report FDA Received Date: 05/06/2026
• Supplement Report FDA Received Date: 06/04/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/19/2025
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: NA.
• Patient Sex: Unknown