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 Code	Dyspnea (1816)
Date of Event	01/02/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported an automated peritoneal dialysis patient was unable to breathe during an unknown process step.The patient was connected to the amia device at the time of the event.The patient reported the device was "not draining enough solution off, and it was leaving around 600 ml or so".According to the reporter the patient then ¿puts in 1400 ml, and they could not breathe¿.The patient performed a manual drain, and the issue was resolved.Renal therapy services initiated a swap of the device and continuous ambulatory peritoneal dialysis was discussed.There was no report of a medical intervention associated with this event.No additional information is available.
Additional Manufacturer Narrative
The device was received for evaluation.Internal and external inspection was performed and no issues were noted.A sample analysis was performed and there was no device malfunction found that could have caused or contributed to the reported events.A short-simulated therapy was successfully performed.A service history review revealed no indication that the parts replaced during servicing caused or contributed to the reported event.A review of the most recent treatment revealed an excessive drain volume of 2306ml during drain 3 of 4, which was greater than the programmed maximum peritoneal volume setting of 2300ml.Review of the device programming revealed the programmed estimated night uf (200ml) 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 748ml.Based on the device log analysis, the probable cause of the reported event was determined to be a user error as the programmed estimated night uf was 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: 18567370
• Report Number: 1416980-2024-00151
• Device Sequence Number: 12791493
• Product Code: FKX
• UDI-Device Identifier: 00085412490120
• UDI-Public: (01)00085412490120
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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): 01/23/2024

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
• Date Returned to Manufacturer: 01/05/2024
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/02/2024
• Initial Report FDA Received Date: 01/23/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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