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	Dyspnea (1816); Abdominal Distention (2601)
Date of Event	03/25/2025
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 during automated peritoneal dialysis (pd) using a amia automated pd cycler, the patient experienced bloatedness and difficulty breathing.The patient was connected during the time of the event.It was reported that the device was not draining for three days.The patient attempted to manually drain, however it was reported that "nothing was coming out".There was no report of medical intervention.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
Additional information: h6 and h11.H11: the device was not received for evaluation.The event history log review showed no keystrokes, programming, or use related events that indicated and/or contributed to the reported issue.The cause of the condition could not be determined.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
• Manufacturer Contact: 25212 w. il route 120; round lake, IL 60073 ; 2242706717
• MDR Report Key: 21853462
• Report Number: 1416980-2025-02261
• Device Sequence Number: 18131154
• Product Code: FKX
• UDI-Device Identifier: 00085412490120
• UDI-Public: (01)00085412490120(11)180312
• Combination Product (Y/N): N
• Initial Reporter State: NY
• 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: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/09/2025

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?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/25/2025
• Supplement Date Received by Manufacturer: 05/29/2025
• Initial Report FDA Received Date: 04/17/2025
• Supplement Report FDA Received Date: 06/09/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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: Other
• Patient Sex: Unknown