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

Catalog Number	5C9320
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Cardiac Arrest (1762); Dyspnea (1816); Heart Failure/Congestive Heart Failure (4446); Increased Intra-Peritoneal Volume (IIPV) (4498)
Date of Event	08/24/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that a patient passed away.It was not reported if the patient was connected to the device at the time of death.The cause of death was reported as cardiac arrest.The patient was hospitalized one day prior to death due to congestive heart failure.It was reported that the patient presented to the hospital with symptoms of fluid overload.It was reported that a code was called due to cardiac arrest/"pea" (pulseless electrical activity) from congestive heart failure.It was reported that an autopsy was not performed.It was not reported if pd therapy was ongoing prior to death or at the time of death.No additional information was available.
Additional Manufacturer Narrative
Should additional relevant information become available, a supplemental report will be submitted.
Additional Manufacturer Narrative
Additional information: b1, d9, h1, h2, h3, h6, h11.H11: the device was received for evaluation.The sample analysis was performed which included an internal and external inspection and a simulated therapy.The device was found to meet specifications for the reported problems.There was no device malfunction found that could have caused or contributed to the reported problem.A review of the sharesource log data revealed there was no evidence of a device malfunction or indications of an increased intraperitoneal volume event associated with the reported event.A service history review was performed and revealed that the device has no previous service events in the last 12 months; therefore, servicing did not cause or contribute to the reported event.No device failure or malfunction was identified that could have caused or contributed to the reported event.The reported condition was verified.The cause of the condition could not be determined.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 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
• Manufacturer Contact: 25212 w. illinois route 120; round lake, IL 60073 ; 2242702068
• MDR Report Key: 20315079
• Report Number: 1416980-2024-05310
• Device Sequence Number: 20869720
• Product Code: FKX
• UDI-Device Identifier: 00085412490120
• UDI-Public: (01)00085412490120(11)180102
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 10/10/2024

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?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/28/2024
• Supplement Date Received by Manufacturer: 09/27/2024
• Initial Report FDA Received Date: 09/26/2024
• Supplement Report FDA Received Date: 10/10/2024
• 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
• Concomitant Medical Products and Therapy/Usage Dates: DIANEAL 2.5%; EXTRANEAL 7.5%
• Outcome Attributed to Adverse Event: Hospitalization; Death; Required Intervention
• Patient Age: 47 YR
• Patient Sex: Male