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

Catalog Number	5C9320
Medical Device Problem Code	Improper or Incorrect Procedure or Method (2017)
Health Effect - Clinical Code	Increased Intra-Peritoneal Volume (IIPV) (4498)
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported an automated peritoneal dialysis (pd) patient experienced ¿overfill" during an unknown process step while using an amia machine.The patient was hospitalized for the event.Treatment was not reported.There was no report of medical intervention associated with this event.At the time of this report, the patient outcome and action taken with pd therapy was not reported.No additional information is available.
Additional Manufacturer Narrative
H11: the device was received for evaluation.A internal and external inspection was performed and no issues were noted.A short simulated therapy was successfully performed.The condition was not reproduced during the sample analysis.The device met specifications.A service history review was performed and revealed that the device has no previous service events.The event history log review revealed the seven most recent therapies showed the patient¿s average uf (ultra-filtration) was approximately 269 ml.The estimated night uf value should be based on an average of the nightly uf from the past seven consecutive therapies for a specific program.The review revealed the programmed estimated night uf (100 ml) may have been set too low for the most recent therapies.Per the amia clinician guide, setting the estimated night uf too low, or to zero may result in a higher risk of iipv (increased intraperitoneal volume).Therefore, based on the device log analysis, the probable cause of the reported event was determined to be the programmed estimated night uf being set too low.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; round lake IL
• Manufacturer (Section G): ECM - BENCHMARK ELECTRONICS INC. - SP011889; 4065 theurer blvd; winona MN
• Manufacturer Contact: 25212 w. il route 120; round lake, IL 60073 ; 2242706717
• MDR Report Key: 22346512
• Report Number: 1416980-2025-03545
• Device Sequence Number: 20962358
• Product Code: FKX
• UDI-Device Identifier: 00085412490120
• UDI-Public: (01)00085412490120(11)200225
• Combination Product (Y/N): N
• Initial Reporter State: NM
• 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: Consumer,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 06/27/2025

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
• Date Returned to Manufacturer: 06/13/2025
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/06/2025
• Initial Report FDA Received Date: 06/27/2025
• 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
• Patient Sex: Unknown