MAUDE Adverse Event Report: BAXTER HEALTHCARE CORPORATION HOMECHOICE CLARIA; SYSTEM, PERITONEAL, AUTOMATIC DELIVERY

Catalog Number	5C6M40
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Dyspnea (1816); Abdominal Distention (2601); Movement Disorder (4412); Swelling/ Edema (4577)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The events occurred on an unspecified date in (b)(6) 2023.The device has been received and the evaluation is in progress.Should additional relevant information become available, a supplemental report will be submitted.
Event or Problem Description
It was reported an automated peritoneal dialysis patient experienced feeling overfilled, swollen abdomen, difficulty breathing and moving during an unknown process step.The patient was connected to the homechoice claria device at the time of the events.The patient stated that for the last week they have been feeling overfilled; however, they did not report it to the pd rn.Renal therapy services (rts) assisted the patient to manually drain, and the patient stated draining helped.Rts initiated a swap of the device and continuous ambulatory peritoneal dialysis was discussed.No additional information is available.
Additional Manufacturer Narrative
Device manufacture date: feb 2023 the device was received for evaluation.Visual inspection did not identify any abnormalities that could have contributed to the reported condition.The sample analysis was performed and there was no device malfunction found that could have caused or contributed to the reported issue.The device was found to meet specifications related to the reported issue.The reported condition was not verified.A review of the device logs revealed the reported issue was determined to be the programmed total uf being set too low.Based on the device evaluation results, the direct cause was determined to be the programmed total uf being set too low (use error).A service history review revealed no indication that the parts replaced during servicing caused or contributed to the reported event.A device history review revealed no issues that could have caused or contributed to the reported issue.Per the claria clinician guide, the programmed total uf should be based on an average of the nightly uf from the past seven consecutive therapies for a specific program.The log data showed that the patient¿s average uf was approximately 1008 ml.Based on the device log analysis, the most likely cause of the reported incident was determined to be the programmed total uf being set too low.Should additional relevant information become available, a supplemental report will be submitted.

• Brand Name: HOMECHOICE CLARIA
• Common Device Name: SYSTEM, PERITONEAL, AUTOMATIC DELIVERY
• Manufacturer (Section D): BAXTER HEALTHCARE CORPORATION; deerfield IL
• Manufacturer (Section G): BAXTER HEALTHCARE - SINGAPORE; 2 woodlands industrial park d; singapore 73875 0; SN 738750
• Manufacturer Contact: 25212 w. illinois route 120; round lake, IL 60073 ; 2242702068
• MDR Report Key: 18088768
• Report Number: 1416980-2023-05756
• Device Sequence Number: 5992880
• Product Code: FKX
• UDI-Device Identifier: 00085412676463
• UDI-Public: (01)00085412676463
• Combination Product (Y/N): N
• Initial Reporter State: SC
• Initial Reporter Country: US
• PMA/510(K) Number: K201867
• 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,Followup
• Report Date (Section B): 12/15/2023

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: 5C6M40
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/20/2023
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: 12/08/2023
• Initial Report FDA Received Date: 11/07/2023
• Supplement Report FDA Received Date: 12/15/2023
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown