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); Malaise (2359)
Date of Event	11/17/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported an automated peritoneal dialysis (pd) patient experienced significant abdominal pain" and "feeling unwell" during fill 3 of 3.The patient was connected to the homechoice claria device at the time of the event.The cycler performed an ¿injection¿ and after the injection the patient experienced the abdominal pain.It was further reported that the patient performed two ¿stasis shunt"; went into drainage; and then completed the pd treatment.The following night, the patient did not perform pd therapy because the patient was not feeling well.The patient presented to the hospital for an abdominal ct scan.No additional information is available.
Additional Manufacturer Narrative
The device was not received for evaluation; therefore, a device analysis could not be completed; however, the sharesource log files associated with homechoice claria were reviewed.The review showed that the end user encountered a low drain volume notice during the 2nd drain cycle with a drain volume of 1336ml.The device logs showed the patient bypassed the low drain volume notice to continue therapy and filled with 2168ml.Per the homechoice claria apd system patient at-home guide, bypassing a low drain volume notice can leave fluid in the peritoneal cavity and result in an increased intraperitoneal volume (iipv) situation.Based on the device log analysis, the reported issue was determined to be the end user bypassing the low drain volume notice during drain (use related 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; singapore 73875 0; SN 738750
• Manufacturer Contact: 25212 w. illinois route 120; round lake, IL 60073 ; 2242702068
• MDR Report Key: 18307169
• Report Number: 1416980-2023-06455
• Device Sequence Number: 6643844
• Product Code: FKX
• UDI-Device Identifier: 00085412676463
• UDI-Public: (01)00085412676463
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• 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: Foreign,Consumer,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 12/11/2023

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?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/21/2023
• Initial Report FDA Received Date: 12/11/2023
• 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: PHYSIONEAL
• Outcome Attributed to Adverse Event: Other
• Patient Age: 58 YR
• Patient Sex: Male