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); Abdominal Distention (2601)
Date of Event	05/31/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Should additional relevant information become available, a supplemental report will be submitted.
Event or Problem Description
It was reported an automated peritoneal dialysis (pd) patient experienced bloatedness and "having issues to breathe" during an unknown process step.The patient was connected to the homechoice device at the time of the event.The patient was in the hospital for an unspecified condition.There was no report of medical intervention associated with this event.At the time of this report, the patient outcome and action taken with pd therapy was not reported.No additional information is available.

• Brand Name: HOMECHOICE APD SYSTEM
• Common Device Name: SYSTEM, PERITONEAL, AUTOMATIC DELIVERY
• Manufacturer (Section D): VANTIVE US HEALTHCARE LLC; round lake IL
• Manufacturer (Section G): VANTIVE HEALTHCARE - SINGAPORE; 2 woodlands industrial park d; street 2; singapore ; SN
• Manufacturer Contact: 25212 w. il route 120; round lake, IL 60073 ; 2242706717
• MDR Report Key: 22309991
• Report Number: 9612057-2025-00047
• Device Sequence Number: 12743850
• Product Code: FKX
• UDI-Device Identifier: 00085412007021
• UDI-Public: 00085412007021
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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: Consumer,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 06/23/2025

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?: No
• Operator of Device: Lay User/Patient
• Device Catalogue Number: 5C4471
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/31/2025
• Initial Report FDA Received Date: 06/23/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): No
• 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: Unknown