HOMECHOICE CLARIA
Report
- Report Number
- 9612057-2025-00039
- Event Type
- Malfunction
- Date Received
- May 19, 2025
- Date of Event
- April 25, 2025
- Report Date
- June 11, 2025
- Manufacturer
- VANTIVE US HEALTHCARE LLC
- Product Code
- FKX
- UDI-DI
- 00085412676463
- PMA / PMN Number
- K201867
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TX, US
- Reporter Occupation
- OTHER
- Health Professional
- N
Narratives
SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.
CORRECTION: B1, H1 AND H11. H11: BASED ON ADDITIONAL INFORMATION RECEIVED, THE HOMECHOICE CLARIA WAS DETERMINED NOT TO BE A FACTOR IN THE REPORTED ADVERSE EVENT.
ADDITIONAL INFORMATION: H6 AND H11. H11: THE DEVICE WAS NOT RETURNED FOR EVALUATION; THEREFORE, A DEVICE ANALYSIS COULD NOT BE COMPLETED. THE EVENT HISTORY LOG REVIEW SHOWED NO KEYSTROKES, PROGRAMMING, OR USE RELATED EVENTS THAT INDICATED AND/OR CONTRIBUTED TO THE REPORTED ISSUE. THE CAUSE OF THE CONDITION COULD NOT BE DETERMINED. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.
IT WAS REPORTED AN AUTOMATED PERITONEAL DIALYSIS PATIENT EXPERIENCED "FULLNESS AND DIFFICULTY TO BREATH, A LOT OF PAIN" DURING DRAINING FOUR OF FOUR. THE PATIENT WAS CONNECTED TO THE HOMECHOICE (HC) CLARIA DEVICE AT THE TIME OF THE EVENTS. THERE WAS NO REPORT OF A MEDICAL INTERVENTION ASSOCIATED WITH THIS EVENT. NO ADDITIONAL INFORMATION IS AVAILABLE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 158500 | HOMECHOICE CLARIA | SYSTEM, PERITONEAL, AUTOMATIC DELIVERY | FKX | VANTIVE US HEALTHCARE LLC | NA | NA | 00085412676463 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Female | Other |