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 Code	Dyspnea (1816)
Date of Event	03/25/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
E1: initial reporter address: (b)(6).Should additional relevant information become available, a supplemental report will be submitted.
Event or Problem Description
A peritoneal dialysis (pd) patient experienced shortness of breath during dialysis.It was further reported that the device "kept beeping" unspecified error message and it was not able to be resolved by the nurse.It was reported that the patient had a total of "3500 instilled but only 500 came out".The patient complained of shortness of breath and disconnected himself from the cycler and manually drained.The patient was not hospitalized and no treatment was given.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
The device was not returned for evaluation therefore a device analysis could not be completed.However, the sharesource files associated with the device were reviewed.No therapy data was available the month of when the event occurred.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: 19159116
• Report Number: 1416980-2024-01854
• Device Sequence Number: 7800717
• Product Code: FKX
• UDI-Device Identifier: 00085412490120
• UDI-Public: (01)00085412490120
• Combination Product (Y/N): N
• Initial Reporter State: VA
• 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: Health Professional,Company Representative
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 05/28/2024

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?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/26/2024
• Supplement Date Received by Manufacturer: 05/28/2024
• Initial Report FDA Received Date: 04/22/2024
• Supplement Report FDA Received Date: 05/28/2024
• 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