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 Codes	Abdominal Distention (2601); Hyperkalemia (4824)
Date of Event	02/03/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Should additional relevant information become available, a supplemental report will be submitted.
Event or Problem Description
It was reported that an automated peritoneal dialysis (apd) patient missed treatments while using an amia (apd) machine "because the device was not functioning properly and had to be shut down unexpectedly".It was reported that the patient experienced "bloating" and elevated potassium levels.The patient was hospitalized for unspecified treatment due to the elevated potassium levels.Patient outcome was not reported.Action taken with pd therapy was not reported.No additional information is available.
Additional Manufacturer Narrative
Additional information: 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 was reviewed and identified that two alarms were generated, however they were not duplicated during the evaluation.It is improbable that the two alarms would cause or contribute to any serious/critical harm to the patient.A short simulated therapy was successfully performed.A service history review was performed and revealed that the device has no previous service events in the last 12 months; therefore, servicing did not cause or contribute to the reported event.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: 24446931
• Report Number: 3038195011-2026-00230
• Device Sequence Number: 10254587
• Product Code: FKX
• UDI-Device Identifier: 00085412490120
• UDI-Public: 00085412490120
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K151525
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Consumer,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 04/02/2026

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: 02/14/2026
• Supplement Date Received by Manufacturer: 03/31/2026
• Initial Report FDA Received Date: 02/25/2026
• Supplement Report FDA Received Date: 04/02/2026
• 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
• Concomitant Medical Products and Therapy/Usage Dates: CASSETTE.
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Sex: Unknown