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

Catalog Number	5C6M40
Medical Device Problem Code	Improper or Incorrect Procedure or Method (2017)
Health Effect - Clinical Codes	Dyspnea (1816); Abdominal Distention (2601)
Date of Event	11/16/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that an automated peritoneal dialysis patient experienced feeling bloated and could not breath properly during multiple steps of therapy.The patient was connected to the homechoice claria device at the time of the events.The caregiver reported that the patient performed a manual drain and that the "prescription was changed 2 weeks ago".Renal therapy services (rts) assisted the caregiver to disconnect the patient and advised the caregiver to contact the pd nurse.Rts initiated a swap of the device and continuous ambulatory peritoneal dialysis was discussed.There was no report of medical intervention associated with this event.At the time of this report, the patient outcome was not reported.No additional information is available.
Additional Manufacturer Narrative
G1: device manufacturer postal code: 738750.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
Additional information: h2, h3, h4, h6 and h11.The device was received for evaluation.The sample analysis was performed, and no hardware defect, device failure or malfunction was identified that could have caused or contributed to the reported complaint.A service history review revealed no indication that the parts replaced during servicing caused or contributed to the reported event.A review of the most recent therapies revealed the programmed minimal.Initial drain (10ml) was set below the recommended settings (use error).Per the homechoice claria clinician guide, the programmed minimum initial drain should be set to at least 70% of the expected peritoneal volume (1400ml).Based on the evaluation results, the most probable cause of the reported event was determined to be the programmed minimal initial drain being set too low in the most recent therapies.Based on the review of the therapy log data, use error of the claria therapy program (minimum initial drain programmed too low) probably caused or contributed to the reported events.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; street 2; singapore ; SN
• Manufacturer Contact: 25212 w. illinois route 120; round lake, IL 60073 ; 2242702068
• MDR Report Key: 20903319
• Report Number: 1416980-2024-07159
• Device Sequence Number: 18400290
• Product Code: FKX
• UDI-Device Identifier: 00085412676463
• UDI-Public: 00085412676463
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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): 01/07/2025

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: 11/22/2024
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/16/2024
• Supplement Date Received by Manufacturer: 12/18/2024
• Initial Report FDA Received Date: 12/11/2024
• Supplement Report FDA Received Date: 01/07/2025
• 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: CASSETTE
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown