NA R5C4479Recalls & reported problems

Summary

The FDA's MAUDE database contains 373 adverse event reports that list this exact device (DI 00085412030531), received between Apr 2, 2018 and Sep 23, 2026 — classified as 2 injuries, 371 malfunctions.

The most frequently reported specific device problem is “Fluid/Blood Leak” (175 reports).

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 16, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 373 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 23, 2026Fluid/Blood Leak

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50875526 ↗
• MalfunctionJun 12, 2026Fluid/Blood Leak; Protective Measures Problem

  IT WAS REPORTED THAT A HOMECHOICE DEVICE EXPERIENCED A SYSTEM ERROR 2240 (AIR IN LINE/SET) ALARM. IT WAS NOT SPECIFIED IF THE PATIENT WAS CONNECTED AT THE TIME OF THE ALARM. THIS OCCURRED DURING AN UNSPECIFIED STEP OF PERITONEAL DIALYSIS THERAPY. DURING TROUBLESHOOTING, IT WAS REPORTED THAT THERE WAS A LEAK FROM AN UNSPECIFIED LOCATION OF THE CASSETTE THAT LED TO THIS ALARM. 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 25484374 ↗
• MalfunctionMay 27, 2026Scratched Material

  IT WAS REPORTED THAT THERE WERE SCRATCHES ON AN UNSPECIFIED QUANTITY OF HOMECHOICE CASSETTES. THIS WAS IDENTIFIED DURING SETUP OF THE DEVICES FOR PERITONEAL DIALYSIS THERAPY. 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 25302611 ↗
• MalfunctionMay 22, 2026Fitting Problem; Protective Measures Problem

  IT WAS REPORTED THAT A HOMECHOICE DEVICE EXPERIENCED A SYSTEM ERROR 2240 (AIR IN LINE/SET) ALARM. IT WAS NOT REPORTED IF THE PATIENT WAS CONNECTED AT THE TIME OF THE ALARM. THIS OCCURRED DURING USE OF THE DEVICE FOR PERITONEAL DIALYSIS THERAPY. DURING TROUBLESHOOTING, IT WAS REPORTED THAT THE "CONNECTOR DOES NOT SCREW PROPERLY ONTO THE LINES" BETWEEN THE SUPPLY LINE OF THE HOMECHOICE CASSETTE AND THE SUPPLY BAG THAT LED TO THIS ALARM. 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 25262804 ↗
• MalfunctionMay 22, 2026Loose or Intermittent Connection; Protective Measures Problem

  IT WAS REPORTED THAT A HOMECHOICE DEVICE EXPERIENCED A SYSTEM ERROR 2240 (AIR IN LINE/SET) ALARM. IT WAS NOT REPORTED IF THE PATIENT WAS CONNECTED AT THE TIME OF THE ALARM. THIS OCCURRED DURING USE OF THE DEVICE FOR PERITONEAL DIALYSIS THERAPY. DURING TROUBLESHOOTING, IT WAS REPORTED THAT THERE WAS A LOOSE CONNECTION BETWEEN THE SUPPLY LINE OF THE HOMECHOICE CASSETTE AND THE SUPPLY BAG THAT LED TO THIS ALARM. 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 25257351 ↗
• MalfunctionMay 15, 2026Disconnection

  IT WAS REPORTED THAT THE PULL RING CAP ON AN UNSPECIFIED LINE OF THE HOMECHOICE CASSETTE DETACHED. THIS OCCURRED BEFORE USE OF THE DEVICE FOR PERITONEAL DIALYSIS THERAPY. 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 25182506 ↗
• MalfunctionMay 14, 2026Component Missing

  IT WAS REPORTED THAT THE PULL RING CAP ON AN UNSPECIFIED LINE OF THE HOMECHOICE CASSETTE WAS MISSING. THIS WAS IDENTIFIED BEFORE USE OF THE DEVICE FOR PERITONEAL DIALYSIS THERAPY. 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 25173700 ↗
• MalfunctionMay 7, 2026Disconnection

  IT WAS REPORTED THAT THE PULL RING CAP DETACHED FROM THE TUBING OF THE HOMECHOICE CASSETTE. THIS OCCURRED BEFORE USE OF THE DEVICE FOR PERITONEAL DIALYSIS THERAPY. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25113588 ↗
• MalfunctionMay 5, 2026Incomplete or Inadequate Connection

  IT WAS REPORTED THAT THERE WAS A CONNECTION ISSUE BETWEEN THE HOMECHOICE CASSETTE AND PHYSIONEAL BAG. THE CONNECTION WAS ¿FUTILE AND NOT TIGHT.¿ THIS OCCURRED DURING PRIME OF PERITONEAL DIALYSIS THERAPY. 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 25085564 ↗
• MalfunctionMay 5, 2026Fitting Problem

  IT WAS REPORTED THAT FOUR (4) HOMECHOICE CASSETTES HAD A CONNECTION ISSUE; DESCRIBED AS "WHILE OPENING THE CASSETTE PATIENT CABLE LID AND CHECKING, THERE IS NO THREADED GROOVE ON THE INSIDE OF THE PATIENT CABLE INLET, SO IT CANNOT BE CONNECTED TO THE INSIDE OF THE BODY CONNECTOR¿. THIS WAS IDENTIFIED DURING SETUP AND PREPARATION FOR PERITONEAL DIALYSIS THERAPY. 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 25082970 ↗
• MalfunctionMay 4, 2026Fluid/Blood Leak; Protective Measures Problem

  IT WAS REPORTED THAT A HOMECHOICE DEVICE EXPERIENCED A SYSTEM ERROR 2240 (AIR IN LINE/SET) ALARM. THE PATIENT WAS CONNECTED AT THE TIME OF THE ALARM. THIS OCCURRED DURING USE OF THE DEVICE FOR PERITONEAL DIALYSIS THERAPY. DURING TROUBLESHOOTING, IT WAS REPORTED THAT THERE WAS A LEAK AT THE CONNECTION BETWEEN SUPPLY LINE OF THE HOMECHOICE CASSETTE AND THE SUPPLY BAG THAT LED TO THIS ALARM. THE PATIENT WAS ADVISED TO END THE THERAPY SESSION. 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 25069099 ↗
• MalfunctionMay 1, 2026Fluid/Blood Leak

  IT WAS REPORTED THAT A HOMECHOICE CASSETTE LEAKED AT THE DIALYSIS SOLUTION INLET. THIS OCCURRED DURING PREPARATION OF THE DEVICE FOR PERITONEAL DIALYSIS THERAPY; DESCRIBED AS THIS OCCURRED IN THE PROCESS OF CONNECTING THE PHYSIONEAL BAG ¿TO THE REFILL LINE¿. 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 25056371 ↗
• MalfunctionApr 29, 2026Material Puncture/Hole

  IT WAS REPORTED THAT THERE WAS A TEAR IN THE HOSE (TUBING) OF A HOMECHOICE CASSETTE. THIS WAS IDENTIFIED DURING USE OF THE DEVICE FOR PERITONEAL DIALYSIS THERAPY. 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 25033066 ↗
• MalfunctionApr 28, 2026Fitting Problem

  IT WAS REPORTED THAT THERE WAS A CONNECTION ISSUE BETWEEN THE HOMECHOICE CASSETTE AND PHYSIONEAL BAG; DESCRIBED AS ¿THE INJECTION PART WAS SEPARATED.¿ THIS OCCURRED DURING SETUP OF THE DEVICE FOR PERITONEAL DIALYSIS THERAPY. 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 25016097 ↗
• MalfunctionApr 27, 2026Fluid/Blood Leak; Protective Measures Problem

  IT WAS REPORTED THAT A HOMECHOICE DEVICE EXPERIENCED A SYSTEM ERROR 2240 (AIR IN LINE/SET) ALARM. THE PATIENT WAS CONNECTED AT THE TIME OF THE ALARM. THIS OCCURRED DURING USE OF THE DEVICE FOR PERITONEAL DIALYSIS THERAPY. DURING TROUBLESHOOTING, IT WAS REPORTED THAT THERE WAS A LEAK FROM AN UNSPECIFIED LOCATION THAT LED TO THIS ALARM. DIALYSATE WAS FLOWING ON THE FLOOR UNDER THE 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 25004917 ↗
• MalfunctionApr 21, 2026Material Puncture/Hole

  IT WAS REPORTED THAT THERE WAS A HOLE IN THE SET OF THE HOMECHOICE CASSETTE. THIS WAS IDENTIFIED DURING SETUP OF THE DEVICE FOR PERITONEAL DIALYSIS THERAPY. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24942272 ↗
• MalfunctionApr 21, 2026Break

  IT WAS REPORTED THAT TWO (2) HOMECHOICE CASSETTES WERE ¿SQUASHED.¿ THIS WAS IDENTIFIED BEFORE USE OF THE DEVICES FOR PERITONEAL DIALYSIS THERAPY. 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 24940613 ↗
• MalfunctionApr 20, 2026Fluid/Blood Leak

  IT WAS REPORTED THAT A HOMECHOICE CASSETTE LEAKED FROM AN UNSPECIFIED LOCATION. THIS OCCURRED DURING USE OF THE DEVICE FOR PERITONEAL DIALYSIS THERAPY. 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 24925477 ↗
• MalfunctionApr 16, 2026Fluid/Blood Leak

  IT WAS REPORTED THAT THERE WAS A LEAK AT THE CONNECTION OF THE HEATER LINE ON THE HOMECHOICE CASSETTE AND PHYSIONEAL BAG. THIS OCCURRED DURING FILL OF PERITONEAL DIALYSIS THERAPY. 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 24897109 ↗
• MalfunctionApr 16, 2026Fluid/Blood Leak; Loose or Intermittent Connection; Protective Measures Problem

  IT WAS REPORTED THAT A HOMECHOICE DEVICE EXPERIENCED A SYSTEM ERROR 2240 (AIR IN LINE/SET) ALARM. THE PATIENT WAS CONNECTED AT THE TIME OF THE ALARM. THIS OCCURRED DURING FILL TWO OF FOUR OF PERITONEAL DIALYSIS THERAPY. DURING TROUBLESHOOTING, IT WAS REPORTED THAT THERE WAS A LOOSE CONNECTION BETWEEN THE HEATER LINE OF THE HOMECHOICE CASSETTE AND THE HEATER BAG, WHICH RESULTED IN A LEAK THAT LED TO THIS ALARM. RENAL THERAPY SERVICES (RTS) ADVISED THE PATIENT TO DISCONNECT AND TO CONTACT THEIR NURSE REGARDING THE ISSUE. 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 24895130 ↗
• MalfunctionApr 9, 2026Device Contamination with Chemical or Other Material

  IT WAS REPORTED THAT THERE WAS A BLACK STAIN INSIDE THE TUBING OF A HOMECHOICE CASSETTE. THIS WAS IDENTIFIED BEFORE USE OF THE DEVICE FOR PERITONEAL DIALYSIS THERAPY. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24829747 ↗
• MalfunctionApr 3, 2026Device Contamination with Chemical or Other Material

  IT WAS REPORTED THAT THERE WERE ¿BLACK DOTS¿ INSIDE THE STERILE FLUID PATHWAY OF A HOMECHOICE AUTOMATED PD SET WITH CASSETTE. THIS WAS IDENTIFIED BEFORE USE OF THE DEVICE FOR PERITONEAL DIALYSIS THERAPY. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24781344 ↗
• MalfunctionApr 3, 2026Crack

  IT WAS REPORTED THAT THERE WERE CRACKS IN SIX (6) HOMECHOICE CASSETTES. THIS WAS IDENTIFIED DURING USE OF THE DEVICES FOR PERITONEAL DIALYSIS THERAPY. 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 24777794 ↗
• MalfunctionApr 2, 2026Loose or Intermittent Connection

  IT WAS REPORTED THAT THERE WAS A CONNECTION ISSUE BETWEEN THE HOMECHOICE CASSETTE AND PHYSIONEAL BAG. THE CONNECTION WAS NOT FASTENED WELL. THIS OCCURRED DURING SETUP OF THE DEVICE FOR PERITONEAL DIALYSIS THERAPY. 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 24767255 ↗
• MalfunctionApr 2, 2026Break; Fluid/Blood Leak

  IT WAS REPORTED THAT A HOMECHOICE CASSETTE WAS DAMAGED WHICH RESULTED IN A LEAK. THIS OCCURRED DURING USE OF THE DEVICE FOR PERITONEAL DIALYSIS THERAPY. 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 24765604 ↗