MAUDE Adverse Event Report: BAXTER HEALTHCARE CORPORATION AMIA AUTOMATED PD SYSTEM; 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	06/18/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported an automated peritoneal dialysis (pd) patient experienced ¿issues with breathing and feeling full¿ during an unknown process step.The patient was connected to the amia device at the time of the event.It was reported that the patient was in the hospital for an unspecified indication at the time of the event.The patient manually drained and ended therapy.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
Should additional relevant information become available, a supplemental report will be submitted.
Additional Manufacturer Narrative
The device was received for evaluation.Internal visual inspection revealed connections were correct and secure no evidence of moisture or pest infestation, and no internal part damage.A sample analysis was performed, and no device failure or malfunction was identified that could have caused or contributed to the reported event.A short simulated therapy was successfully performed.All connections appear correct and secure.A service history review revealed no indication that the parts replaced during servicing caused or contributed to the reported event.The sharesource log files associated with the amia cycler were reviewed.A review of the most recent treatments revealed an excessive drain volume of 2916 ml during drain 2 of 3, which was greater than the programmed maximum peritoneal volume setting of 2800 ml.The prescription programming revealed the programmed estimated night uf (0 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.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 61 ml.Based on the device log analysis, there was evidence of an iipv event and the probable cause was determined to be user error of 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 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: 19697290
• Report Number: 1416980-2024-03462
• Device Sequence Number: 8066634
• Product Code: FKX
• UDI-Device Identifier: 00085412490120
• UDI-Public: (01)00085412490120(11)200325
• 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): 08/16/2024

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
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/18/2024
• Supplement Date Received by Manufacturer: 08/14/2024
• Initial Report FDA Received Date: 07/08/2024
• Supplement Report FDA Received Date: 08/22/2024
• 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: Other
• Patient Sex: Unknown