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	04/12/2026
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 use of the device for peritoneal dialysis therapy.During troubleshooting, it was reported that there was a leak at the connection between supply line of the homechoice cassette and the supply bag that led to this alarm.The patient was advised to end the therapy session.There was no report of patient injury or medical intervention associated with this event.No additional information is available.
Additional Manufacturer Narrative
D4: the lot number is unknown, therefore, only a primary di number could be provided.Should additional relevant information become available, a supplemental report will be submitted.
Additional Manufacturer Narrative
Additional information was added to d9, h3, h6 and h11.H11: the device was received for evaluation.Visual inspection did not identify any abnormalities that could have contributed to the reported condition.Under water pressure testing was performed and no leaks or issues were observed.Functional test including self-test and priming were performed and no issues were observed.The reported condition was not verified.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 HEALTHCARE - SINGAPORE; 2 woodlands industrial park d; street 2; singapore 73777 8; SN 737778
• Manufacturer Contact: 510 lake cook rd; deerfield, il, IL 60015 ; 8153072966
• MDR Report Key: 25069099
• Report Number: 9612057-2026-00057
• Device Sequence Number: 21422082
• Product Code: FKX
• UDI-Device Identifier: 00085412030531
• UDI-Public: 0085412030531
• Combination Product (Y/N): N
• Initial Reporter Country: KS
• 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,Consumer,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/01/2026

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?: Device Returned to Manufacturer
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/12/2026
• Supplement Date Received by Manufacturer: 05/20/2026
• Initial Report FDA Received Date: 05/04/2026
• Supplement Report FDA Received Date: 06/01/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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: PHYSIONEAL 40 2.5% 5L.
• Patient Sex: Unknown