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	Insufficient Information (4580)
Type of Reportable Event	Serious Injury
Event or Problem Description
A study reported an automated peritoneal dialysis (pd) patient experienced volume overload (no further details).The cause of the event was not reported.Peritonitis.It was reported the patient was hospitalized for the event.Treatment, patient outcomes and action taken with pd therapy were not reported.No additional information is available.
Additional Manufacturer Narrative
E1: initial reporter address: (b)(6).Study article: el shamy, o., attalah, s., sharma, s., and uribarri, j."comparing the effect of peritoneal dialysis cycler type on patient-reported satisfaction, support needs and treatments".Bmc nephrology, (2002) 23:217 1 ¿ 5.Https://doi.Org/10.1186/s12882-022-02854-z.Should additional relevant information become available, a supplemental report will be submitted.
Additional Manufacturer Narrative
The device was not returned and the lot number is unknown; therefore, a device analysis could not be completed.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: 17498961
• Report Number: 1416980-2023-04012
• Device Sequence Number: 11346010
• Product Code: FKX
• UDI-Device Identifier: 00085412490120
• UDI-Public: (01)00085412490120
• Combination Product (Y/N): N
• Initial Reporter State: TN
• 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: Study,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/15/2023

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?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/13/2023
• Supplement Date Received by Manufacturer: 09/07/2023
• Initial Report FDA Received Date: 08/10/2023
• Supplement Report FDA Received Date: 09/15/2023
• 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: Hospitalization
• Patient Sex: Unknown