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	Abdominal Distention (2601)
Date of Event	05/09/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported an automated peritoneal dialysis patient experienced "being very full" and "gaining" during therapy using a homechoice (hc) claria device.The hp was connected during the time of the event.Renal therapy services assisted the patient with trouble shooting.The patient went to the hospital where therapy was performed using the hospital device with no issues and no alarms.No additional information is available.
Additional Manufacturer Narrative
Should additional relevant information become available, a supplemental report will be submitted.
Additional Manufacturer Narrative
Additional information: d9, h3, h6 and h11.The device was received for evaluation.The sample analysis was performed; however, functional tests could not be completed due to fluid contamination.The device was scrapped due to fluid contamination.The sharesource log files associated with homechoice claria were reviewed and revealed the patient bypassed multiple low drain volume alerts during the initial drain, to complete their therapy.The homechoice claria patient-at-home guide warns the end user that bypassing a low drain volume notice during the initial drain when there is still fluid left in the peritoneal cavity can result in an increased intraperitoneal volume (iipv) situation later therapy.Based on the device log analysis, there was evidence of iipv and the probable cause of the reported issue was determined to be the patient bypassing the low drain volume alarm during the initial drain (use error).A service history review was performed and revealed that the device has no previous service events; therefore, servicing did not cause or contribute to the reported event.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: 19386799
• Report Number: 1416980-2024-02500
• Device Sequence Number: 14448522
• Product Code: FKX
• UDI-Device Identifier: 00085412676463
• UDI-Public: (01)00085412676463
• Combination Product (Y/N): N
• Initial Reporter State: VA
• 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): Unknown
• Reporter Type: Manufacturer
• Report Source: Consumer,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 07/08/2024

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?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/09/2024
• Supplement Date Received by Manufacturer: 07/05/2024
• Initial Report FDA Received Date: 05/23/2024
• Supplement Report FDA Received Date: 07/08/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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: Hospitalization
• Patient Sex: Unknown