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	08/31/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
G1: device manufacturer postal code: (b)(6).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 full and difficulty breathing during dwell 1 of 2.The patient was connected to the homechoice claria at the time of the events.Renal therapy services (rts) assisted the patient to stop therapy and perform a manual drain.The patient reported they felt better after draining.It was reported the device drained 3928ml.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.No additional information is available.
Additional Manufacturer Narrative
Additional information: the device was not received for evaluation; therefore, a device analysis could not be completed; however, review of the event history log files associated with homechoice claria cycler were reviewed.A review of the most recent therapy revealed the patient performed a manual drain of 3928ml after receiving 2200ml during fill 1 of 2.A review of the device programming revealed the programmed i-drain alarm (0ml) may have been set too low for the most recent treatment.Per the homechoice claria apd system patient at-home guide, the programmed minimum i-drain volume should be set to at least 70% to 95% of the programmed last fill volume.Based on the device log analysis, the probable cause of the reported event was determined to be the programmed minimum i-drain volume being set too low, use error.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: 20273112
• Report Number: 1416980-2024-05167
• Device Sequence Number: 3470430
• Product Code: FKX
• UDI-Device Identifier: 00085412676463
• UDI-Public: (01)00085412676463(11)230425
• Combination Product (Y/N): N
• Initial Reporter State: NC
• 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): 10/25/2024

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: 08/31/2024
• Supplement Date Received by Manufacturer: 10/22/2024
• Initial Report FDA Received Date: 09/20/2024
• Supplement Report FDA Received Date: 10/25/2024
• 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
• Concomitant Medical Products and Therapy/Usage Dates: NI.
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown