MAUDE Adverse Event Report: Vantive US Healthcare LLC HOMECHOICE APD SET; System, Peritoneal, Automatic Delivery

Catalog Number	5C4469C
Medical Device Problem Code	Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/09/2026
Type of Reportable Event	Malfunction

• Brand Name: HOMECHOICE 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 ; +1(815)307-2966
• MDR Report Key: 50521144
• Report Number: 2314912-2026-00563
• Device Sequence Number: 13430679
• Product Code: FKX
• UDI-Device Identifier: 07332414208479
• UDI-Public: (01)07332414208479(10)H26A06013(17)310106
• Combination Product (Y/N): N
• Initial Reporter State: NA
• Initial Reporter Country: US
• PMA/510(K) Number: K923065
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative
• Type of Report: Initial,Followup
• Report Date (Section B): 09/29/2026

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: Other
• Device Catalogue Number: 5C4469C
• Device Lot Number: H26A06013
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/10/2026
• Supplement Date Received by Manufacturer: 09/24/2026
• Initial Report FDA Received Date: 08/31/2026
• Supplement Report FDA Received Date: 09/29/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/06/2026
• 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
• Patient Sex: Unknown