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); Loose or Intermittent Connection (1371); Protective Measures Problem (3015)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/23/2026
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 two of four of peritoneal dialysis therapy.During troubleshooting, it was reported that there was a loose connection between the heater line of the homechoice cassette and the heater bag, which resulted in a leak that led to this alarm.Renal therapy services (rts) advised the patient to disconnect and to contact their nurse regarding the issue.There was no report of patient injury or medical intervention associated with this event.No additional information is available.
Additional Manufacturer Narrative
G1: the device was manufactured at one of the following facilities: vantive healthcare ¿ singapore, 2 woodlands industrial park d, street 2 singapore, singapore 737778.Vantive healthcare ¿ tunisia, route de chebbaou km 12, oued ellil 2021 tunsia.An alarm indicative of a potential malfunction of the disposable cassette was reported.The device was not returned and the lot number is unknown; therefore, a device analysis could not be completed.However, a loose connection was reported between the heater line of the homechoice cassette and the heater bag, which resulted in a leak, which is known to cause this alarm.The cause of the loose connection could not be determined.Should additional relevant information become available, a supplemental report will be submitted.

• 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 US HEALTHCARE LLC; ni; ni; ni
• Manufacturer Contact: 510 lake cook rd; deerfield, il, IL 60015 ; 8153072966
• MDR Report Key: 24895130
• Report Number: 3038195011-2026-00384
• Device Sequence Number: 13381122
• Product Code: FKX
• UDI-Device Identifier: 00085412030531
• UDI-Public: 0085412030531
• Combination Product (Y/N): N
• Initial Reporter State: NY
• 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
• Report Date (Section B): 04/16/2026

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: R5C4479
• Device Lot Number: ASKU
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/23/2026
• Initial Report FDA Received Date: 04/16/2026
• 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: DIANEAL LOW CAL 2.5%; HOMECHOICE CLARIA
• Patient Sex: Unknown