MAUDE Adverse Event Report: BAXTER HEALTHCARE CORPORATION AMIA AUTOMATED PD SYSTEM; SYSTEM, PERITONEAL, AUTOMATIC DELIVERY

Catalog Number	5C9320
Medical Device Problem Code	Fire (1245)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/19/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
H10: the device was received for evaluation.During visual inspection a missing enclosure lid and scratches were noted on the display.There was no evidence related to the reported issue (e.G., smoke, burnt components, or fire) during the evaluation.The machine underwent pressure integrity test and the device performed according to product specifications.A short, simulated therapy was successfully performed.The reported condition was not verified.The manufacturing record review was performed, and no issues were found during the prior servicing related to the reported complaint.Review of the prior service record revealed the device passed all electrical safety test(s) prior to release with no issues noted.Should additional relevant information become available, a supplemental report will be submitted.
Event or Problem Description
It was reported an amia automated pd system caught on fire.The patient was connected at the time however, it was not specified what process step of peritoneal dialysis therapy the event occurred.The patient was in a camper, and it was not reported if the outlet was grounded (or if the unit was plugged into a generator, 30amp, or 50amp outlet).Renal therapy services (rts) initiated a swap of the device and continuous ambulatory peritoneal dialysis was discussed.There was no report of patient injury or 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: 17565795
• Report Number: 1416980-2023-04153
• Device Sequence Number: 6657913
• Product Code: FKX
• UDI-Device Identifier: 00085412490120
• UDI-Public: (01)00085412490120
• Combination Product (Y/N): N
• Initial Reporter State: IN
• 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): 08/17/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• 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
• Date Returned to Manufacturer: 08/01/2023
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/19/2023
• Initial Report FDA Received Date: 08/17/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown