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

Catalog Number	5C6M40
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Dyspnea (1816); Nausea (1970); Abdominal Distention (2601)
Date of Event	10/14/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Should additional relevant information become available, a supplemental report will be submitted.
Event or Problem Description
It was reported that an automated peritoneal dialysis (pd) patient experienced feelings of being bloated, difficulty breathing and nausea during dwell 1 of 5.The patient was connected to the homechoice claria device at the time of the events.The patient ended therapy and performed a manual drain.According to the patient, draining relieved the symptoms and they were feeling better.Renal therapy services (rts) reviewed the therapy log and the program.No recent change in the program was observed.Rts initiated the swap of the device and continuous ambulatory peritoneal dialysis (capd) was discussed.No additional information is available.
Additional Manufacturer Narrative
Additional information: b1, h1, h6 and h11.The device was not received for evaluation.The event history log review showed no keystrokes, programming, or use related events that indicated and/or contributed to the reported issue.Review of the sharesource therapy file revealed no excessive fill or drain volumes indicative of increased intraperitoneal volume (iipv).The reported issue was not verified.The cause of the condition could not be determined.Based on additional information received, homechoice claria was determined not to be a factor in the reported adverse event.Should additional relevant information become available, a supplemental report will be submitted.

• Brand Name: HOMECHOICE CLARIA
• 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 73777 8; SN 737778
• Manufacturer Contact: 25212 w. il route 120; round lake, IL 60073 ; 2242706717
• MDR Report Key: 23490284
• Report Number: 9612057-2025-00128
• Device Sequence Number: 15591579
• Product Code: FKX
• UDI-Device Identifier: 00085412676463
• UDI-Public: 0085412676463
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• Initial Reporter Country: US
• PMA/510(K) Number: K201867
• 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,Followup
• Report Date (Section B): 01/05/2026

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: 5C6M40
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/14/2025
• Supplement Date Received by Manufacturer: 12/12/2025
• Initial Report FDA Received Date: 11/06/2025
• Supplement Report FDA Received Date: 01/05/2026
• 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