Model note · Peritoneal Dialysis
Baxter Homechoice Claria APD System
The Homechoice Claria is an automated peritoneal dialysis (APD) cycler that runs overnight exchanges for adult and paediatric patients at home, and can also be used in hospitals. It cycles prescribed volumes of PD solution through a disposable cassette and links to the Sharesource platform, so clinicians can review treatment data and send prescription changes that the patient must accept on the cycler before they take effect.
The model
Maker, model and type.
- Maker
- Baxter Healthcare Corporation (kidney care business now operating as Vantive)
- Model
- Homechoice Claria APD System with Sharesource
- Device type
- Peritoneal Dialysis
- Main document
- Open the public document
Key specifications
What the public record says.
| Item | Value | Source |
|---|---|---|
| Product codes | 5C6M40 (Claria APD System, US 510(k)); 5C6M00 (230 V) and 5C6M10 (115/230 V) listed in a Baxter field notice | Source |
| Sharesource product code | 5CGM01 | Source |
| Patients and setting | Adult and paediatric renal failure patients, home healthcare environment and comparable use in professional facilities | Source |
| Display and controls | Two-line OLED screen, control buttons, on-screen step instructions and auto-dim for night use | Source |
| Programs | Four therapy programs, chosen by the clinician in the Sharesource clinical portal | Source |
| Remote programming | Two-way, not real time; patient must review and accept changes before the cycler uses them | Source |
| Regulatory class | FDA Class II peritoneal dialysis system, 21 CFR 876.5630, product code FKX; predicate HomeChoice and HomeChoice PRO (K102936) | Source |
Recalls
Known FDA recalls.
- Z-0409-20262025-08-28
Sharesource Claria software defect could stop updated prescription settings being saved on the patient's cycler.
FDA record - BfArM 07312/17 (Baxter FCA-2017-017)2017-07-25
Field notice: cassettes damaged when sets are opened with tools may have undetected holes, risking air delivery to the patient.
FDA record
Safety
Safety warnings from the record.
- An undetected cassette hole can deliver air at 10 to 30 mL/min during fill or dwell, which may cause painful pneumoperitoneum. Source
- Sharesource is not a real-time monitor and cannot programme the cycler in real time; it is not a substitute for clinical management. Source
- Improper or incorrect procedure is the most common specific problem term in MAUDE reports for this cycler, so user training and technique are worth checking in any incident review. Source
Sources
Where this note comes from.
- FDA 510(k) K201867 summary, Homechoice Claria APD System and Sharesource
- Vantive Homechoice Claria product page
- Baxter field notice on cassette damage (via BfArM)
- openFDA MAUDE problem counts, brand HOMECHOICE CLARIA
Not covered: The Claria Patient At-Home Guide, the alarm update clinic letter and any service manual could not be opened (Baxter links now redirect to Vantive), so alarm messages, fill volume ranges, heater temperature, power and battery data are not included.
BMEssentia knowledge drafted from public information, reviewed by Hasan Khaled Ismail on 2026-10-24. Always follow the manufacturer's instructions for use and service manual.
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