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); Nausea (1970); Vomiting (2144); Abdominal Distention (2601)
Date of Event	02/13/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Should additional relevant information become available, a supplemental report will be submitted.
Event or Problem Description
It was reported that an automated peritoneal dialysis patient experienced a distended abdomen, feeling too full, nausea, vomiting and trouble breathing during an unreported process step of pd therapy.The patient was connected to the amia device at the time of the event.Renal therapy services (rts) advised the patient to inform the registered nurse of missed therapy since the patient did not want to perform therapy "tonight".Rts initiated a swap of the device and discussed the use of continuous ambulatory peritoneal dialysis.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 short simulated therapy was successfully performed.The event history log review showed no keystrokes, programming, or use related events that indicated and/or contributed to the reported issue.A service history review revealed no indication that the parts replaced during servicing caused or contributed to the reported event.The reported condition was not verified.The cause of the condition could not be determined.Should additional relevant information become available, a supplemental report will be submitted.
Additional Manufacturer Narrative
The sample analysis was performed and the device was found to meet specifications for the reported problem.There was no device malfunction found that could have caused or contributed to the reported problem.Based on additional information received, the amia device was determined not to be a factor in the reported adverse event.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: 18827596
• Report Number: 1416980-2024-00906
• Device Sequence Number: 12732446
• Product Code: FKX
• UDI-Device Identifier: 00085412490120
• UDI-Public: (01)00085412490120
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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,Followup
• Report Date (Section B): 04/22/2024

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?: Yes
• 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: 02/13/2024
• Supplement Date Received by Manufacturer: 04/05/2024; 04/17/2024
• Initial Report FDA Received Date: 03/04/2024
• Supplement Report FDA Received Date: 04/12/2024; 04/22/2024
• 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