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

Catalog Number	5C4471
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Dyspnea (1816); Pain (1994); Abdominal Distention (2601)
Date of Event	06/08/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported an automated peritoneal dialysis patient experienced feeling full; difficulty breathing and drain pain during drain 4 of 5.The patient was connected to the homechoice device at the time of the events.According to the reporter, a manual drain was performed.It was reported that pd therapy was discontinued with a total uf of 913 ml.Renal therapy services initiated a swap of the device and continuous ambulatory peritoneal dialysis was discussed.There was no report of medical intervention associated with this event.The reporter stated the symptoms were resolved.No additional information is available.
Additional Manufacturer Narrative
The device has been received and the evaluation is in progress.Should additional relevant information become available, a supplemental report will be submitted.

• Brand Name: HOMECHOICE APD SYSTEM
• 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: 25642131
• Report Number: 9612057-2026-00072
• Device Sequence Number: 10022689
• Product Code: FKX
• UDI-Device Identifier: 00085412007021
• UDI-Public: 0085412007021
• Combination Product (Y/N): N
• Initial Reporter State: DC
• 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): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 07/16/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Lay User/Patient
• Device Catalogue Number: 5C4471
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/15/2026
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/08/2026
• Supplement Date Received by Manufacturer: 07/13/2026
• Initial Report FDA Received Date: 06/26/2026
• Supplement Report FDA Received Date: 07/16/2026
• 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: Reuse
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Female