MAUDE Adverse Event Report: VANTIVE US HEALTHCARE LLC HOMECHOICE AUTOMATED PD SET WITH CASSETTE; SYSTEM, PERITONEAL, AUTOMATIC DELIVERY

Catalog Number	R5C4479
Medical Device Problem Codes	Fluid/Blood Leak (1250); Protective Measures Problem (3015)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/19/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
D4: lot #: suspect lots 25e07t020, 23e13t037, 25e13t039.Should additional relevant information become available, a supplemental report will be submitted.
Event or Problem Description
It was reported that a homechoice device experienced a system error 2240 (air in line/set) alarm.It was not specified if the patient was connected at the time of the alarm.This occurred during an unspecified step of peritoneal dialysis therapy.During troubleshooting, it was reported that there was a leak from an unspecified location of the cassette that led to this alarm.There was no report of patient injury or medical intervention associated with this event.No additional information is available.

• Brand Name: HOMECHOICE AUTOMATED PD SET WITH CASSETTE
• Common Device Name: SYSTEM, PERITONEAL, AUTOMATIC DELIVERY
• Manufacturer (Section D): VANTIVE US HEALTHCARE LLC; deerfield IL
• Manufacturer (Section G): VANTIVE HEALTHCARE - TUNISIA; route de chebbaou km 12; oued ellil 2021 tunsia; tunis ; TS
• Manufacturer Contact: 510 lake cook rd; deerfield, il, IL 60015 ; 8153072966
• MDR Report Key: 25484374
• Report Number: 3006755813-2026-00044
• Device Sequence Number: 10521032
• Product Code: FKX
• UDI-Device Identifier: 00085412030531
• UDI-Public: 0085412030531
• Combination Product (Y/N): N
• Initial Reporter Country: NO
• 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: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• 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: Lay User/Patient
• Device Catalogue Number: R5C4479
• Device Lot Number: ASKU
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/19/2026
• Initial Report FDA Received Date: 06/12/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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: HOMECHOICE CLARIA.
• Patient Sex: Male