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

Catalog Number	5C4471
Medical Device Problem Code	Unintended Electrical Shock (4018)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/14/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the operator felt an electric shock in their hand when the homechoice device was turned on or off using the switch on the back.This was described as a ¿felt a pull¿.This occurred during an unspecified step of automated peritoneal dialysis therapy.The patient was not connected at the time of the event.There was no report of patient injury or medical intervention associated with this event.No additional information is available.
Additional Manufacturer Narrative
The device has been received and the evaluation is in progress.Should additional relevant information become available, a supplemental report will be submitted.

• Brand Name: HOMECHOICE APD SYSTEM
• Common Device Name: SYSTEM, PERITONEAL, AUTOMATIC DELIVERY
• Manufacturer (Section D): VANTIVE US HEALTHCARE LLC; deerfield IL
• Manufacturer (Section G): VANTIVE HEALTHCARE - LARGO; 7511 114th avenue north; null; largo FL 33773
• Manufacturer Contact: 510 lake cook rd; deerfield, il, IL 60015 ; 8153072966
• MDR Report Key: 25127535
• Report Number: 1036337-2026-00004
• Device Sequence Number: 12926984
• Product Code: FKX
• UDI-Device Identifier: 00085412007021
• UDI-Public: (01)00085412007021
• Combination Product (Y/N): N
• Initial Reporter Country: MX
• 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,Consumer,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/29/2026

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: Lay User/Patient
• Device Catalogue Number: 5C4471
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/27/2026
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/14/2026
• Supplement Date Received by Manufacturer: 05/26/2026
• Initial Report FDA Received Date: 05/08/2026
• Supplement Report FDA Received Date: 05/29/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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
• Patient Sex: Unknown