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 Code	Dyspnea (1816)
Date of Event	04/03/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
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 shortness of breath during a fill.The patient was connected to the homechoice claria device at the time of the event.The patient requested to end therapy and wanted to drain.Renal therapy services (rts) assisted the patient with ending therapy and a manual drain.The fill volume was 1970 ml.Rts initiated a swap of the device and discussed the use of continuous ambulatory peritoneal dialysis.There was no report of a medical intervention associated with this event.No additional information is available.
Additional Manufacturer Narrative
The device was not received for evaluation; therefore, a device analysis could not be completed; however, the sharesource log files associated with homechoice claria were reviewed.A review of the most recent therapy showed that the patient¿s average uf for the seven most recently completed therapies was approximately 650 ml and that the patient's programmed total uf (250 ml) was set too low for the most recent therapies.There was no device malfunction identified that could have caused or contributed to the reported issue.Based on the device log analysis, the most probable cause was determined to be the programmed total uf being set too low.Per the claria clinician guide, the product labelling warns users and clinicians that this may lead to accumulation of peritoneal fluid during the course of therapy, because of the undrained uf, which may cause symptoms in some patients.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: 19183019
• Report Number: 1416980-2024-01898
• Device Sequence Number: 12540057
• Product Code: FKX
• UDI-Device Identifier: 00085412676463
• UDI-Public: (01)00085412676463
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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): 06/05/2024

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?: No
• Operator of Device: Lay User/Patient
• Device Catalogue Number: 5C6M40
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/03/2024
• Supplement Date Received by Manufacturer: 05/31/2024
• Initial Report FDA Received Date: 04/25/2024
• Supplement Report FDA Received Date: 06/05/2024
• 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