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

Catalog Number	L5C4531
Medical Device Problem Codes	Disconnection (1171); Protective Measures Problem (3015)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/09/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that a homechoice device experienced a system error 2240 (air in line/set) alarm.The patient was connected at the time of the alarm.This occurred during dwell three of five of peritoneal dialysis therapy.During troubleshooting, it was reported that there was a disconnection between the supply line of the homechoice cassette and the supply bag that led to this alarm.Renal therapy services (rts) instructed the caregiver to close the transfer set and to disconnect the patient from the cycler.Rts advised the caregiver to contact the nurse regarding the missed therapy.There was no report of patient injury or medical intervention associated with this event.No additional information is available.
Additional Manufacturer Narrative
Should additional relevant information become available, a supplemental report will be submitted.
Additional Manufacturer Narrative
Additional information was added to d9, h3, h6, and h11: h11: the device was received for evaluation with the tubing cut and the slide clamp and cap missing.Visual inspection was performed and a cut in the tubing was observed which may have caused the sliding clamp and cap to come loose.Due to the nature of the sample, no further evaluation could be performed.The reported issue could not be verified or refuted.A batch review was conducted and there were no deviations found related to this reported condition during the manufacture of this lot.Should additional relevant information become available, a supplemental report will be submitted.

• Brand Name: INTERGRATED APD SET
• Common Device Name: SYSTEM, PERITONEAL, AUTOMATIC DELIVERY
• Manufacturer (Section D): VANTIVE US HEALTHCARE LLC; deerfield IL
• Manufacturer (Section G): ECM - BAXTER HEALTHCARE - HAINA; piisa industrial park antigua; carretera sanchez km 18 1/2; haina, san cristobal 91000 ; DR 91000
• Manufacturer Contact: 510 lake cook rd; deerfield, il, IL 60015 ; 8153072966
• MDR Report Key: 25049734
• Report Number: 3038195011-2026-00434
• Device Sequence Number: 9920968
• Product Code: FKX
• UDI-Device Identifier: 00085412090078
• UDI-Public: (01)00085412090078(10)DR25F17055(17)300617
• Combination Product (Y/N): N
• Initial Reporter State: AL
• 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: Consumer,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/08/2026

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: L5C4531
• Device Lot Number: DR25F17055
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/09/2026
• Supplement Date Received by Manufacturer: 06/08/2026
• Initial Report FDA Received Date: 04/30/2026
• Supplement Report FDA Received Date: 06/08/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/17/2025
• 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: DIANEAL LOW CA 1.5%; HOMECHOICE CLARIA
• Patient Sex: Unknown