MAUDE Adverse Event Report: BAXTER INTERNATIONAL INC. AMIA AUTOMATED PD CYCLER; SYSTEM, PERITONEAL, AUTOMATIC DELIVERY

Catalog Number	5C9320
Medical Device Problem Code	Protective Measures Problem (3015)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/01/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that an amia device experienced a high priority alarm 20198.The patient was connected at the time of the alarm.This occurred during an unspecified process step of peritoneal dialysis therapy.During troubleshooting, it was reported that the door of the amia device was opened.Renal therapy services (rts) assisted the home patient (hp) to start over with new supplies.Rts advised the hp to contact their peritoneal dialysis registered nurse regarding the issue.Rts discussed continuous ambulatory peritoneal dialysis with the hp.There was no report of patient injury or medical intervention associated with this event.No additional information is available.
Additional Manufacturer Narrative
D4: the lot number is unknown, therefore, only a primary di number could be provided.The device has been received and the evaluation is in progress.Should additional relevant information become available, a supplemental report will be submitted.
Additional Manufacturer Narrative
Correction h8 and h11: h8: usage of device: remove initial use of dev and replace with reuse h11: remove statement ¿the lot number is unknown¿ as the device has a serial number instead of a lot number.Additional information: h3, h6 and h11.H11: the device was received for evaluation.An internal visual inspection revealed connections correct, secured and no evidence of moisture or pest infestation and no internal part damage.A short-simulated therapy was performed and when prompted to close the door, the door was very easy to close and the latch and catch mechanism functionied properly.Therapy was completed successfully and at the end of therapy when prompt to open the door, the door opened very easily.The reported issue of the door is open alert (door is open 20198) was verified, but not duplicated during analysis.The device was determined to meet specifications for the reported issue of door is open 20198.The cause of the reported issue of door is open 20198 was undetermined.The event history log review showed door is open 20198 was present in the log.A service history review revealed no indication that the parts replaced during servicing caused or contributed to the reported event.Should additional relevant information become available, a supplemental report will be submitted.

• Brand Name: AMIA AUTOMATED PD CYCLER
• Common Device Name: SYSTEM, PERITONEAL, AUTOMATIC DELIVERY
• Manufacturer (Section D): BAXTER INTERNATIONAL INC.; 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: 20076799
• Report Number: 1416980-2024-04549
• Device Sequence Number: 20434324
• Product Code: FKX
• UDI-Device Identifier: 00085412490120
• UDI-Public: 00085412490120
• Combination Product (Y/N): N
• Initial Reporter State: MI
• 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: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/26/2024

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: 08/08/2024
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/01/2024
• Supplement Date Received by Manufacturer: 09/25/2024
• Initial Report FDA Received Date: 08/27/2024
• Supplement Report FDA Received Date: 09/26/2024
• 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
• Patient Sex: Unknown