MAUDE Adverse Event Report: BAXTER HEALTHCARE CORPORATION AMIA AUTOMATED PD SYSTEM; SYSTEM, PERITONEAL, AUTOMATIC DELIVERY

Catalog Number	5C9320
Medical Device Problem Code	Improper or Incorrect Procedure or Method (2017)
Health Effect - Clinical Codes	Abdominal Pain (1685); Dyspnea (1816); Abdominal Distention (2601)
Date of Event	08/31/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported the patient experienced fullness, stomach tightness, and shortness of breath.The patient was connected for peritoneal dialysis (pd) therapy at the time of this event.During troubleshooting, it was determined that the estimated night ultrafiltration (uf) setting was too low.The patient would raise the bed slightly to help with drain speed in the meantime and would sit up during the extra drain required to drain all remaining uf more efficiently.At the time of this report, pd therapy was ongoing.No additional information is available.
Additional Manufacturer Narrative
Should additional relevant information become available, a supplemental report will be submitted.
Additional Manufacturer Narrative
The device was not received for evaluation; therefore, a device analysis could not be completed; however, the sharesource log files associated with amia cycler were reviewed.Review of the device programming revealed the programmed estimated night uf (600ml) may have been set too low for the most recent therapies.The log data of the seven most recent therapies showed the patient¿s average uf was approximately 1500 ml.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.The amia automated pd system patient guide explains the estimated night uf settings, provides treatment and programming answers on the settings.The guide also provides warnings regarding settings being set too low.Should additional relevant information become available, a supplemental report will be submitted.

• Brand Name: AMIA AUTOMATED PD SYSTEM
• Common Device Name: SYSTEM, PERITONEAL, AUTOMATIC DELIVERY
• Manufacturer (Section D): BAXTER HEALTHCARE CORPORATION; deerfield IL
• Manufacturer (Section G): BENCHMARK ELECTRONICS INC.; 4065 theurer blvd; winona MN 55987
• Manufacturer Contact: 25212 w. illinois route 120; round lake, IL 60073 ; 2242702068
• MDR Report Key: 17852847
• Report Number: 1416980-2023-04959
• Device Sequence Number: 3390490
• Product Code: FKX
• UDI-Device Identifier: 00085412490120
• UDI-Public: (01)00085412490120
• Combination Product (Y/N): N
• Initial Reporter State: GA
• 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,Followup
• Report Date (Section B): 11/21/2023

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
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/05/2023
• Supplement Date Received by Manufacturer: 10/27/2023
• Initial Report FDA Received Date: 10/02/2023
• Supplement Report FDA Received Date: 11/21/2023
• 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: Unknown
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown