MAUDE Adverse Event Report: VANTIVE US HEALTHCARE LLC AMIA AUTOMATED PD CYCLER; SYSTEM, PERITONEAL, AUTOMATIC DELIVERY

Catalog Number	5C9320
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Loss of consciousness (2418)
Date of Event	02/18/2026
Type of Reportable Event	Death
Additional Manufacturer Narrative
Dont submit yet - awaiting for the aware date.Might need to change it b2: date of death: patient passed away in (b)(6) 2026.Should additional relevant information become available, a supplemental report will be submitted.
Event or Problem Description
It was reported that a peritoneal dialysis patient passed away "during therapy" while using an amia device.The cause of death was unknown.It was reported that the patient lost consciousness during therapy and was sent "to the intensive care unit (icu) of a hospital".The patient subsequently passed away the next day.It was not reported if an autopsy was performed.It was reported that the patient "coded while connected to the machine".It was not reported if the patient was connected at the time of death.No additional information was available.
Additional Manufacturer Narrative
Correction: b2.Device evaluation: d9, h3, h6 and h11.H11: the device was received for evaluation.Visual inspection did not identify any abnormalities that could have contributed to the reported condition.The event history log review showed no keystrokes, programming, or use related events that indicated and/or contributed to the reported issue.Functional returned instrument testing was performed which included volumetric verification and the device passed all testing.A short simulated therapy was successfully performed.A service history review was performed and revealed that the device has no previous service events; therefore, servicing did not cause or contribute to the reported event.The reported condition was not verified.The cause of the condition could not be determined.No device failure or malfunction was identified that could have caused or contributed to the reported event.Should additional relevant information become available, a supplemental report will be submitted.

• Brand Name: AMIA AUTOMATED PD CYCLER
• Common Device Name: SYSTEM, PERITONEAL, AUTOMATIC DELIVERY
• Manufacturer (Section D): VANTIVE US HEALTHCARE LLC; deerfield IL
• Manufacturer (Section G): ECM - BENCHMARK ELECTRONICS INC. - SP011889; 4065 theurer blvd; winona MN 55987
• Manufacturer Contact: 510 lake cook rd; deerfield, il, IL 60015 ; 8153072966
• MDR Report Key: 24630062
• Report Number: 3038195011-2026-00299
• Device Sequence Number: 13015537
• Product Code: FKX
• UDI-Device Identifier: 00085412490120
• UDI-Public: (01)00085412490120
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 04/14/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Lay User/Patient
• Device Catalogue Number: 5C9320
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/19/2026
• Supplement Date Received by Manufacturer: 04/09/2026
• Initial Report FDA Received Date: 03/18/2026
• Supplement Report FDA Received Date: 04/14/2026
• 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
• Outcome Attributed to Adverse Event: Hospitalization; Death
• Patient Sex: Unknown