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

Catalog Number	5C6M40
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Abdominal Pain (1685); Dyspnea (1816); Abdominal Distention (2601)
Date of Event	06/26/2024
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 (pd) patient experienced "trouble breathing" and "feeling bloated with abdominal pain" during the first fill while connected to the homechoice claria device.The patient drain manually and felt "better".It was not reported if the patient was hospitalized.There was no report of medical intervention associated with this event.At the time of this report, it was reported that the patient "restarted with new supplies." no additional information is available.
Additional Manufacturer Narrative
Additional information: h11: the device was not returned for evaluation; therefore, a sample analysis could not be completed.The sharesource logs were reviewed and the therapy logs revealed the programmed minimum initial drain volume (0ml) was set too low due to a previous incomplete therapy.There was no hardware defect or device malfunction identified that could have caused or contributed to the reported problem.Based on the device evaluation results, the probable cause of the reported event was determined to be use error, as the minimum initial drain volume being set too low due to a previous incomplete therapy.Per the homechoice claria apd system patient at-home guide, if the previous therapy ended early for any reason or an off-cycler exchange was performed, there may be more fluid in your peritoneal cavity than normal.If this occurs, the minimum initial drain volume (min i-drain vol) may be set too low.The minimum initial drain volume setting should be set to at least 70% of the expected peritoneal volume.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 ; SN
• Manufacturer Contact: 25212 w. illinois route 120; round lake, IL 60073 ; 2242702068
• MDR Report Key: 19779125
• Report Number: 1416980-2024-03723
• Device Sequence Number: 12831649
• Product Code: FKX
• UDI-Device Identifier: 00085412676463
• UDI-Public: (01)00085412676463(11)230419
• Combination Product (Y/N): N
• Initial Reporter State: IN
• 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): 09/06/2024

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?: Yes
• 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: 06/26/2024
• Supplement Date Received by Manufacturer: 08/23/2024
• Initial Report FDA Received Date: 07/18/2024
• Supplement Report FDA Received Date: 09/06/2024
• 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: Female