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

Catalog Number	5C4469C
Medical Device Problem Code	Device Contamination with Chemical or Other Material (2944)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/04/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that there was particulate matter (pm) inside the tubing of a homechoice automated pd set with cassette.This was observed while priming the device for peritoneal dialysis (pd) therapy.There was no patient involvement.No additional information is available.
Additional Manufacturer Narrative
D4: the lot number is unknown, therefore, only a primary di number could be provided.E1: initial reporter facility name: (b)(6).Should additional relevant information become available, a supplemental report will be submitted.
Additional Manufacturer Narrative
Additional information was added to h6 and h11: h11: the actual device was not available; however, a photograph of the sample was provided for evaluation.The photograph was reviewed and showed a black partially encapsulated particulate matter inside the tubing.The reported condition was verified.The particulate matter was determined to be intrinsic to the manufacturing process, identified as pin buildup of burnt plastic material broken off during the tubing extrusion process.Should additional relevant information become available, a supplemental report will be submitted.

• Brand Name: HOMECHOICE APD SET
• Common Device Name: SYSTEM, PERITONEAL, AUTOMATIC DELIVERY
• Manufacturer (Section D): VANTIVE US HEALTHCARE LLC; round lake IL
• Manufacturer (Section G): VANTIVE HEALTHCARE - MOUNTAIN HOME; 1900 north highway 201; mountain home AR 72653
• Manufacturer Contact: 25212 w. il route 120; round lake, IL 60073 ; 2242706717
• MDR Report Key: 23477641
• Report Number: 2314912-2025-01097
• Device Sequence Number: 18701491
• Product Code: FKX
• UDI-Device Identifier: 07332414208479
• UDI-Public: 7332414208479
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K923065
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 11/26/2025

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: Health Professional
• Device Catalogue Number: 5C4469C
• 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: 10/09/2025
• Supplement Date Received by Manufacturer: 11/18/2025
• Initial Report FDA Received Date: 11/05/2025
• Supplement Report FDA Received Date: 11/26/2025
• 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
• Patient Sex: Unknown