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 Code	Increased Intra-Peritoneal Volume (IIPV) (4498)
Date of Event	11/21/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported an automated peritoneal dialysis patient experienced "overfill" while using homechoice claria device.It was reported that the patient "had over 1500ml and managed to bypass before the first fill in the treatment which caused overfill and had over 3500ml pd fluid in the stomach".The patient was hospitalized.Treatment was not reported.Action taken with pd therapy was not reported.At the time of this report, the patient outcome was not reported.No additional information is available.
Additional Manufacturer Narrative
The device was not returned; therefore, a device analysis could not be completed.A review of the therapy log data from sharesource revealed the patient drained 182ml and bypassed a low drain volume alert during the initial drain cycle.The homechoice claria apd system patient at-home guide warns that bypassing a low drain volume notice during initial drain when there is still fluid left in the peritoneal cavity can result in an increased intraperitoneal volume (iipv) situation later in therapy.The probable cause of the reported event was determined to be the use error specified as user bypassing the low drain volume notice during the initial drain.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: 23839994
• Report Number: 9612057-2025-00145
• Device Sequence Number: 15813726
• Product Code: FKX
• UDI-Device Identifier: 00085412676463
• UDI-Public: (01)00085412676463(11)210301
• Combination Product (Y/N): N
• Initial Reporter Country: SW
• 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: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 12/18/2025

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: 5C6M40
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/21/2025
• Initial Report FDA Received Date: 12/18/2025
• 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: Hospitalization
• Patient Age: 74 YR
• Patient Sex: Male