HomeChoice APD System 5C4471RRecalls & reported problems
Baxter International Inc. · The HomeChoice Automated Personal Cycler is intended for automatic control of dialysate solution exchanges in the treatment of pediatric and adult renal failure patients undergoing peritoneal dialysis. · Class 2
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00085412007038), received between Dec 17, 2025 and Dec 17, 2025 — classified as 1 malfunction.
The most frequently reported specific device problem is “Unintended Electrical Shock” (1 report).
Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.
Reports received per month
Most reported problems
Device problems
- Unintended Electrical Shock1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionDec 17, 2025Unintended Electrical Shock; Unintended Electrical Shock
IT WAS REPORTED THAT A PATIENT EXPERIENCED ELECTRICAL SHOCK IN THEIR HAND WITH A DURING USE WITH A HOMECHOICE CLARIA CYCLER. THERE WAS NO REPORT OF PATIENT INJURY OR MEDICAL INTERVENTION ASSOCIATED WITH THIS EVENT. NO ADDITIONAL INFORMATION IS AVAILABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23828681 ↗
Other SYSTEM, PERITONEAL, AUTOMATIC DELIVERY devices
- Liberty® Select Cycler 180343Fresenius Medical Care Holdings, Inc. · System, peritoneal, automatic delivery1 recall545 deaths15,896 reports
- Liberty® 050-87216Fresenius Medical Care Holdings, Inc. · SYSTEM, PERITONEAL, AUTOMATIC DELIVERY16 deaths9,148 reports
- Liberty® 050-87212Fresenius Medical Care Holdings, Inc. · SYSTEM, PERITONEAL, AUTOMATIC DELIVERY12 deaths2,169 reports
- Liberty® 180111Fresenius Usa, Inc. · SYSTEM, PERITONEAL, AUTOMATIC DELIVERY126 deaths1,716 reports
- Amia Automated PD Set with Cassette 5C5479Baxter International Inc. · SYSTEM, PERITONEAL, AUTOMATIC DELIVERY1 recall976 reports
- INTERGRATED APD SET L5C4531Baxter International Inc. · SYSTEM, PERITONEAL, AUTOMATIC DELIVERY811 reports
- Liberty 050-87216AFresenius Medical Care Renal Therapies Group, LLC · System, Peritoneal, Automatic Delivery1 death678 reports
- NA R5C4479Baxter Healthcare SA · System, peritoneal, automatic delivery373 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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