MAUDE Adverse Event Report: VANTIVE US HEALTHCARE LLC LOW RECIRCULATION VOLUME APD SET; SYSTEM, PERITONEAL, AUTOMATIC DELIVERY

Catalog Number	N5C8305C
Medical Device Problem Codes	Disconnection (1171); Loose or Intermittent Connection (1371)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/24/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
D4: lot #: the customer reported two potential lot numbers: h25l17043, expiration: 2030-12-17 and h25g27066, expiration: 2030-07-27 should additional relevant information become available, a supplemental report will be submitted.
Event or Problem Description
It was reported that the patient line of a homechoice low recirculation volume apd set with cassette had a connection issue with the patient¿s transfer set and disconnected.This was described as ¿the patient line from cassette is not connected well to the patient's transfer set¿ and ¿the patient became disconnected from the machine.¿ this occurred during use of the device for automated peritoneal dialysis therapy.There was no report of patient injury or medical intervention associated with this event however, the patient received an installation of prophylactic antibiotics, intraperitoneally.No additional information is available.

• Brand Name: LOW RECIRCULATION VOLUME APD SET
• Common Device Name: SYSTEM, PERITONEAL, AUTOMATIC DELIVERY
• Manufacturer (Section D): VANTIVE US HEALTHCARE LLC; deerfield IL
• Manufacturer (Section G): VANTIVE HEALTHCARE - MOUNTAIN HOME; 1900 north highway 201; mountain home AR 72653
• Manufacturer Contact: 510 lake cook rd; deerfield, il, IL 60015 ; 8153072966
• MDR Report Key: 25428628
• Report Number: 2314912-2026-00334
• Device Sequence Number: 10205061
• Product Code: FKX
• UDI-Device Identifier: 00085412087672
• UDI-Public: 0085412087672
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• Initial Reporter Country: US
• PMA/510(K) Number: K102936
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 07/08/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Lay User/Patient
• Device Catalogue Number: N5C8305C
• Device Lot Number: ASKU
• 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: 05/11/2026
• Supplement Date Received by Manufacturer: 07/07/2026
• Initial Report FDA Received Date: 06/08/2026
• Supplement Report FDA Received Date: 07/08/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: HOMECHOICE DEVICE.; TRANSFER SET.
• Patient Age: 17 MO
• Patient Sex: Unknown