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	Dyspnea (1816)
Date of Event	06/25/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported an automated peritoneal dialysis (pd) patient experienced difficulty with breathing during an unknown process step.The patient was not connected to the amia device at the time of the event.There was no report of hospitalization or 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.Visual inspection did not identify any abnormalities that could have contributed to the reported condition.An external and internal inspection was performed and no issues were noted.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.No device failure or malfunction was identified that could have caused or contributed to the reported event.Review of the event history log revealed data from the seven (7) most recent therapies showed the patient¿s average uf was approximately 1402 ml.The programmed estimated night uf (150ml) was below the recommended setting.Per the amia clinician guide, 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 and setting the estimated night uf too low, or to zero may result in a higher risk of iipv.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): BENCHMARK ELECTRONICS INC; 4065 theurer blvd; winona MN 55987
• Manufacturer Contact: 25212 w. il route 120; round lake, IL 60073 ; 2242706717
• MDR Report Key: 22501852
• Report Number: 1416980-2025-03744
• Device Sequence Number: 18261876
• Product Code: FKX
• UDI-Device Identifier: 00085412490120
• UDI-Public: (01)00085412490120(11)180516
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• 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: Consumer,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 07/14/2025

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: 07/01/2025
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/25/2025
• Initial Report FDA Received Date: 07/14/2025
• 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
• Concomitant Medical Products and Therapy/Usage Dates: NI.
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown