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	Abdominal Pain (1685); Dyspnea (1816); Eructate (1839); Abdominal Distention (2601)
Date of Event	07/12/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported an automated peritoneal dialysis (pd) patient experienced symptoms of overfill, bloating, breathing difficulty, burping, and abdominal pain during dwell 1 of 4.The patient was connected to the homechoice claria device at the time of the events.The patient reported the last three nights they had experienced the events.According to the patient they were overfilled so they called their pdrn and were advised to call renal therapy services (rts) to help drain.Rts assisted the caregiver with performing a manual drain.It was further reported, the patient "felt much better¿.Rts initiated a swap of the device and continuous ambulatory peritoneal dialysis was discussed.There was no report of medical intervention associated with the event.No additional information is available.
Additional Manufacturer Narrative
The device was received for evaluation.Internal and external inspection was performed, and no issues were noted.All connections appear correct and secure.A service history review revealed no indication that the parts replaced during servicing caused or contributed to the reported event.No device failure or malfunction was identified that could have caused or contributed to the reported event.Review of the sharesource therapy log data was performed and revealed the programmed total uf (50ml) may have been set too low for the most recent therapies.Per the homechoice 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 from the most recent treatments showed the patient¿s average uf was approximately 480ml.Based on the device log analysis, the direct cause of the reported fullness event 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: 17499837
• Report Number: 1416980-2023-04015
• Device Sequence Number: 17768322
• Product Code: FKX
• UDI-Device Identifier: 00085412676463
• UDI-Public: (01)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
• Report Date (Section B): 08/10/2023

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: 07/21/2023
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/15/2023
• Initial Report FDA Received Date: 08/10/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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: Male