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	Abdominal Pain (1685); Dyspnea (1816)
Date of Event	12/12/2025
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 patient experienced abdominal pain, overfill, and difficulty breathing during a dwell 5/5.The patient was connected to the homechoice claira device at the time of the events.The caregiver reported to renal therapy services (rts) that they needed to perform a manual drain because patient didn´t feel good.Rts assisted the caregiver with the manual drain.The drain volume was more than 3368 ml.After draining, the patient reported they felt better and rts assisted with ending therapy.Rts initiated a swap of the device and continuous ambulatory peritoneal dialysis was discussed.There was no report of medical intervention associated with this event.No additional information is available.
Additional Manufacturer Narrative
Additional information: b1, d9, h1, h3, h6 and h11.The device was received for evaluation.Visual inspection did not identify any abnormalities that could have contributed to the reported condition.A review of the most recent treatment initiated and revealed no excessive fill or drain volumes compared to the clinician programming.During dwell 5 of 5, the patient initiated a manual drain of 3418ml and subsequently ended their therapy.There was no evidence of a device malfunction and no indication(s) of an iipv event associated with the reported complaint.Based on the device log analysis, there were no findings that could have caused or contributed to the reported issue.A short-simulated therapy was successfully performed.A service history review was performed and revealed that the device has no previous service events; 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.The reported condition was not verified.The cause of the condition could not be determined.Based on additional information received, the 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: 510 lake cook rd; deerfield, il, IL 60015 ; 8153072966
• MDR Report Key: 23994397
• Report Number: 9612057-2026-00002
• Device Sequence Number: 13395867
• Product Code: FKX
• UDI-Device Identifier: 00085412676463
• UDI-Public: (01)00085412676463(11)240516
• Combination Product (Y/N): N
• Initial Reporter State: ND
• 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): 01/23/2026

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?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/12/2025
• Supplement Date Received by Manufacturer: 01/16/2026
• Initial Report FDA Received Date: 01/07/2026
• Supplement Report FDA Received Date: 01/23/2026
• 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: NI.
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown