MAUDE Adverse Event Report: VANTIVE US HEALTHCARE LLC SHARESOURCE CONNECTIVITY PLATFORM; SYSTEM, PERITONEAL, AUTOMATIC DELIVERY

Catalog Number	5C9400
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	02/26/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Additional information: h6 and h11.H11: a review of the two patients¿ device program settings for therapies were performed.In both patients¿ settings, the total expected ultrafiltration (uf) was configured at precisely 7%, the minimum value required for the confirmation warning not to trigger.There was no divergence between the device program settings prescribed in sharesource versus the settings used for the patients' treatments.No defect or nonconformance with sharesource was identified, and sharesource was confirmed to function as intended.The reported condition of "flooded/outflow mode" was not verified.Sharesource was determined to function as per specification.As per the sharesource connectivity platform user guide for use with the home pd system kaguya, "[sharesource] is not intended to be a substitute for good clinical management practices, nor does its operation create decisions or treatment pathways." should additional relevant information become available, a supplemental report will be submitted.
Additional Manufacturer Narrative
Should additional relevant information become available, a supplemental report will be submitted.
Event or Problem Description
It was reported that two automated peritoneal dialysis (pd) patients using kaguya cyclers with sharesource were hospitalized due to "flooding", further described as "outflow mode".The reporter further informed that difficulty was encountered with some of the parameters programmed in sharesource, including the "disconnect state", whereby patients seem to end therapy "still flooded".There was no report of patient symptoms.There was no report of medical intervention associated with this event.At the time of this report, the patient outcome and action taken with pd therapy was not reported.Additional information has been requested to provide details about the event.
Additional Manufacturer Narrative
Additional information: b5 and b7.B5: upon follow up, it was reported that the patient was discharged from the hospital "a few days later".No additional information is available at this time.Should additional relevant information become available, a supplemental report will be submitted.

• Brand Name: SHARESOURCE CONNECTIVITY PLATFORM
• Common Device Name: SYSTEM, PERITONEAL, AUTOMATIC DELIVERY
• Manufacturer (Section D): VANTIVE US HEALTHCARE LLC; deerfield IL
• Manufacturer (Section G): SHARESOURCE SOFTWARE; 510 lake cook rd; deerfield IL 60015
• Manufacturer Contact: 510 lake cook rd; deerfield, il, IL 60015 ; 8153072966
• MDR Report Key: 24716961
• Report Number: 3038195011-2026-00321
• Device Sequence Number: 17645483
• Product Code: FKX
• UDI-Device Identifier: 05413765565694
• UDI-Public: 05413765565694
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K151525
• 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: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 05/22/2026

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: Health Professional
• Device Catalogue Number: 5C9400
• 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: 02/26/2026
• Supplement Date Received by Manufacturer: 04/02/2026; 05/14/2026
• Initial Report FDA Received Date: 03/30/2026
• Supplement Report FDA Received Date: 04/15/2026; 05/22/2026
• 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
• Concomitant Medical Products and Therapy/Usage Dates: KAGUYA CYCLER
• Outcome Attributed to Adverse Event: Hospitalization
• Patient Sex: Unknown