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

Catalog Number	5C6M40
Medical Device Problem Code	Improper or Incorrect Procedure or Method (2017)
Health Effect - Clinical Codes	Dyspnea (1816); Abdominal Distention (2601)
Date of Event	02/13/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
H11: the device was received for evaluation.External visual inspection revealed device to be in good condition.Internal visual inspection revealed connections were correct and secure, no evidence of moisture or pest infestation.A service history review was performed and revealed that the device has no previous service events in the last 12 months; therefore, servicing did not cause or contribute to the reported event.A device history review revealed no issues that could have caused or contributed to the reported issue.Review of the event history log revealed that the programmed minimum initial drain volume (0 ml) may have been set too low for the most recent therapies.The hc patient-at-home guide and the hc clinician guide warn users that if the initial drain volume is not programmed at a minimum of 70% of the last fill volume, the patient is at risk of experiencing overfill.Per the homechoice claria clinician guide, the programmed minimum initial drain should be set to at least 70% of the expected peritoneal volume.Based on the device log analysis, the probable cause of the reported event was determined to be the programmed minimum initial drain volume being set too low.Should additional relevant information become available, a supplemental report will be submitted.
Event or Problem Description
It was reported an automated peritoneal dialysis patient experienced "feeling full and bloated and was having breathing difficulty".The patient was connected to the homechoice claria device at the time of the event.Renal therapy services (rts) had patient end the therapy early and remove supplies.It was reported that the patient will contact peritoneal dialysis registered nurse (pdrn).Rts initiated the swap of the device and continuous ambulatory peritoneal dialysis (capd) was discussed.At the time of this report, the patient outcome was not reported.No additional information is available.

• 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 73777 8; SN 737778
• Manufacturer Contact: 510 lake cook rd; deerfield, il, IL 60015 ; 8153072966
• MDR Report Key: 24575883
• Report Number: 9612057-2026-00026
• Device Sequence Number: 18449980
• Product Code: FKX
• UDI-Device Identifier: 00085412676463
• UDI-Public: 0085412676463
• Combination Product (Y/N): N
• Initial Reporter State: VA
• 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
• Report Date (Section B): 03/11/2026

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?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/18/2026
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/13/2026
• Initial Report FDA Received Date: 03/11/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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
• Concomitant Medical Products and Therapy/Usage Dates: 1.5% UNSPECIFIED SOLUTIONS.
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown