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	Dyspnea (1816); Nausea (1970); Abdominal Distention (2601)
Date of Event	10/16/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device was not received for evaluation; therefore, a device analysis could not be completed; however, a review of the amia device programming revealed the programmed estimated night uf (50ml) 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 0 (zero), may result in a higher risk of iipv.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 log data of the seven most recent therapies showed the patient¿s average uf was approximately 695ml.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 setting be set to low.Should additional relevant information become available, a supplemental report will be submitted.
Event or Problem Description
It was reported that an automated peritoneal dialysis (pd) patient experienced overfullness, difficulty breathing and nausea during fill 1.The patient was connected to the amia device at the time of the events.Reportedly, these symptoms improved after draining.Post-operatively, the pd patient retained a lot of fluid and was not able to handle the standard fill volume (2100ml).Renal therapy services advised the caregiver to contact the pd nurse to have the therapy looked at, where the device filled, the correct amount of each fill and normal drain amount.The device was operational, and a swap was not necessary.There was no medical intervention associated with this event.No additional information is available.

• 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: 18094889
• Report Number: 1416980-2023-05779
• Device Sequence Number: 17640495
• Product Code: FKX
• UDI-Device Identifier: 00085412490120
• UDI-Public: (01)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
• Report Date (Section B): 11/08/2023

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
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/16/2023
• Initial Report FDA Received Date: 11/08/2023
• 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