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	12/30/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device was not received for evaluation; therefore, a device analysis could not be completed; however, the log files associated with the claria device were reviewed.A review of the device logs revealed the programmed min i-drain volume (0ml) was set below the recommended settings in the most recent therapies.The device logs indicated the patient filled with 2544ml during fill 1 of 7 and then subsequently initiated a manual drain of 1536ml.The patient resumed their therapy and drained 2633ml during drain 1.Per the homechoice claria clinician guide, the programmed minimum initial drain should be set to at least 70% of the expected peritoneal volume.If the minimum i-drain volume is set to 0 (zero), it can be associated with a higher risk of iipv due to the possibility of an incomplete drain followed by a full fill volume.Based on the device log analysis, the direct cause of the reported event was determined to be the programmed i-drain alarm being set too low, (use error).Should additional relevant information become available, a supplemental report will be submitted.
Event or Problem Description
It was reported that an automated peritoneal dialysis patient experienced feeling bloated and difficulty breathing during fill 1 of 7.The patient was connected to the homechoice claria device at the time of the events.It was also reported that the patient suspected that they were not draining enough.Renal therapy services (rts) assisted the patient to perform a manual drain which relieved the symptoms.The patient reported they were ¿feeling good¿ and were ¿good¿ to continue therapy.Rts advised the patient to contact the registered nurse.The device was operational, and a swap was not necessary.There was no report of a medical intervention associated with this event.No additional information is available.

• 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: 18553631
• Report Number: 1416980-2024-00115
• Device Sequence Number: 7859057
• 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): 01/22/2024

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
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/30/2023
• Initial Report FDA Received Date: 01/22/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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