MAUDE Adverse Event Report: VANTIVE US HEALTHCARE LLC HOMECHOICE AUTOMATED PD SET WITH CASSETTE; SYSTEM, PERITONEAL, AUTOMATIC DELIVERY

Catalog Number	R5C4479
Medical Device Problem Codes	Fitting Problem (2183); Protective Measures Problem (3015)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
D4: the lot number is unknown, therefore, only a primary di number could be provided.H11: an alarm indicative of a potential malfunction of the disposable cassette was reported.The device was not returned and the lot number is unknown; therefore, a device analysis could not be completed.However, a onnection issue was reported between the connector of the supply line of the homechoice cassette and the supply bag, which is known to cause this alarm.The cause of the connection issue could not be determined.Should additional relevant information become available, a supplemental report will be submitted.
Event or Problem Description
It was reported that a homechoice device experienced a system error 2240 (air in line/set) alarm.It was not reported if the patient was connected at the time of the alarm.This occurred during use of the device for peritoneal dialysis therapy.During troubleshooting, it was reported that the "connector does not screw properly onto the lines" between the supply line of the homechoice cassette and the supply bag that led to this alarm.There was no report of patient injury or medical intervention associated with this event.No additional information is available.

• Brand Name: HOMECHOICE AUTOMATED PD SET WITH CASSETTE
• Common Device Name: SYSTEM, PERITONEAL, AUTOMATIC DELIVERY
• Manufacturer (Section D): VANTIVE US HEALTHCARE LLC; deerfield IL
• Manufacturer (Section G): VANTIVE HEALTHCARE - TUNISIA; route de chebbaou km 12; oued ellil 2021 tunsia; tunis ; TS
• Manufacturer Contact: 510 lake cook rd; deerfield, il, IL 60015 ; 8153072966
• MDR Report Key: 25262804
• Report Number: 3006755813-2026-00039
• Device Sequence Number: 5419539
• Product Code: FKX
• UDI-Device Identifier: 00085412030531
• UDI-Public: 0085412030531
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• 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: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• 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?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Lay User/Patient
• Device Catalogue Number: R5C4479
• 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: 04/28/2026
• Initial Report FDA Received Date: 05/22/2026
• 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 CLARIA.; PHYSIONEAL 1.36% 5L.
• Patient Sex: Unknown