MAUDE Adverse Event Report: VANTIVE US HEALTHCARE LLC INTERGRATED APD SET; SYSTEM, PERITONEAL, AUTOMATIC DELIVERY

Catalog Number	L5C4531
Medical Device Problem Codes	Device Alarm System (1012); Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/28/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that a homechoice device experienced a system error 2240 (air in line/set) alarm.The patient was connected at the time of the alarm.This occurred during fill of peritoneal dialysis therapy.During troubleshooting, it was reported that there was a leak from an unspecified location that led to this alarm.The patient saw fluid on the table where the cycler was located.Renal therapy services (rts) advised the patient to remove the supplies.There was no report of patient injury or medical intervention associated with this event.No additional information is available.
Additional Manufacturer Narrative
Should additional relevant information become available, a supplemental report will be submitted.

• Brand Name: INTERGRATED APD SET
• Common Device Name: SYSTEM, PERITONEAL, AUTOMATIC DELIVERY
• Manufacturer (Section D): VANTIVE US HEALTHCARE LLC; deerfield IL
• Manufacturer (Section G): VANTIVE HEALTHCARE - MOUNTAIN HOME; 1900 north highway 201; mountain home AR 72653
• Manufacturer Contact: 510 lake cook rd; deerfield, il, IL 60015 ; 8153072966
• MDR Report Key: 25240490
• Report Number: 2314912-2026-00304
• Device Sequence Number: 10501243
• Product Code: FKX
• UDI-Device Identifier: 00085412090078
• UDI-Public: 0085412090078
• Combination Product (Y/N): N
• Initial Reporter State: IN
• Initial Reporter Country: US
• PMA/510(K) Number: K102936
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Consumer,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/16/2026

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: Lay User/Patient
• Device Catalogue Number: L5C4531
• Device Lot Number: H26A12037
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/28/2026
• Supplement Date Received by Manufacturer: 06/14/2026
• Initial Report FDA Received Date: 05/21/2026
• Supplement Report FDA Received Date: 06/16/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/12/2026
• 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: DIANEAL LOW CAL 2.5%.; HOMECHOICE CLARIA.
• Patient Sex: Unknown