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); Pain (1994)
Date of Event	07/01/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that an automated peritoneal dialysis patient experienced back pain and breathing problems during last fill.The patient was connected to the homechoice claria device at the time of the events.The patient reported that this was their first time performing therapy.Renal therapy services (rts) attempted to assist the patient to manually drain; however, they pressed the wrong button.The device moved to close all clamps.Rts assisted the patient to end the therapy and remove the cassette.Rts then guided the patient to manually drain.The patient reported that they felt better after the drain; however, the pain stood.Rts requested patient to go to the emergency room and to contact the peritoneal dialysis nurse.There was no report of medical intervention associated with this event.At the time of this report, the patient outcome was not reported.No additional information is available.
Additional Manufacturer Narrative
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; deerfield IL
• Manufacturer (Section G): VANTIVE HEALTHCARE - SINGAPORE; 2 woodlands industrial park d; street 2; singapore NA 73777 8; SN 737778
• Manufacturer Contact: 510 lake cook rd; deerfield, il, IL 60015 ; +1(815)307-2966
• MDR Report Key: 50072906
• Report Number: 9612057-2026-00084
• Device Sequence Number: 10207234
• Product Code: FKX
• UDI-Device Identifier: 00085412676463
• UDI-Public: (01)00085412676463(11)231211
• Combination Product (Y/N): N
• Initial Reporter State: GA
• 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
• Type of Report: Initial,Followup
• Report Date (Section B): 08/25/2026

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?: No
• 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: 07/02/2026
• Supplement Date Received by Manufacturer: 08/13/2026
• Initial Report FDA Received Date: 07/29/2026
• Supplement Report FDA Received Date: 08/25/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 12/11/2023
• 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