AUTOMATED PD SET R5C4479CRecalls & reported problems

Summary

The FDA's MAUDE database contains 228 adverse event reports that list this exact device (DI 00085412088433), received between Jan 3, 2018 and Aug 17, 2026 — classified as 3 injuries, 225 malfunctions.

The most frequently reported specific device problem is “Fluid/Blood Leak” (129 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 228 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 17, 2026Fluid/Blood Leak

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50275483 ↗
• MalfunctionMay 21, 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 DWELL SIX OF SIX OF PERITONEAL DIALYSIS THERAPY. DURING TROUBLESHOOTING, IT WAS REPORTED THAT THERE WAS A LEAK FROM AN UNSPECIFIED LOCATION THAT LED TO THIS ALARM. THE CYCLER DOOR WAS WET AND THE PATIENT LINE FELT STICKY. RENAL THERAPY SERVICES (RTS) ADVISED THE CAREGIVER TO REMOVE THE SUPPLIES AND TO PERFORM A MANUAL DRAIN. 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 25240445 ↗
• MalfunctionMay 5, 2026Air/Gas in Device

  IT WAS REPORTED THAT THERE WERE AIR BUBBLES IN THE TUBING OF THE HOMECHOICE CASSETTE WITHOUT AN ASSOCIATED ALARM. THIS WAS IDENTIFIED DURING INITIAL DRAIN 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 25082377 ↗
• MalfunctionMay 4, 2026Device Contamination with Chemical or Other Material

  IT WAS REPORTED THAT SOMETHING WAS NOTICED INSIDE THE FILL LINE OF A HOMECHOICE AUTOMATED PD SET WITH CASSETTE; THIS WAS DESCRIBED AS IT ¿FELT SQUISHY LIKE RUBBER¿. THIS WAS IDENTIFIED WHEN HOOKING THE DEVICE UP TO DO PERITONEAL DIALYSIS (PD) THERAPY. IMMEDIATELY UPON NOTICING THIS ISSUE, THE HOME PATIENT REPLACED THE DEVICE. 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 25070698 ↗
• MalfunctionApr 21, 2026Device Contamination with Chemical or Other Material

  IT WAS REPORTED THAT THERE WAS A BROWN SMEAR ON 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 24940737 ↗
• MalfunctionApr 1, 2026Device Contamination with Chemical or Other Material

  IT WAS REPORTED THAT BLACK SPOTS WERE OBSERVED INSIDE AN UNSPECIFIED QUANTITY OF 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 24753491 ↗
• MalfunctionMar 6, 2026Fluid/Blood Leak

  IT WAS REPORTED THAT THE HEATER LINE OF THE HOMECHOICE CASSETTE LEAKED. THIS OCCURRED DURING DRAIN FOUR OF FIVE OF PERITONEAL DIALYSIS THERAPY. RENAL THERAPY SERVICES (RTS) INSTRUCTED THE PATIENT TO CLOSE ALL CLAMPS AND DISCONNECT. 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 24530306 ↗
• MalfunctionMar 2, 2026Disconnection; Fluid/Blood Leak

  IT WAS REPORTED THAT AN UNSPECIFIED LINE OF THE HOMECHOICE CASSETTE DISCONNECTED 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 24485065 ↗
• MalfunctionFeb 16, 2026Fluid/Blood Leak; Material Puncture/Hole; Material Split, Cut or Torn

  IT WAS REPORTED THAT THERE WAS A HOLE IN THE PATIENT LINE OF THE HOMECHOICE CASSETTE WHICH RESULTED IN A LEAK. THE HOLE WAS AT THE DISTAL END OF THE TUBING CLOSE TO THE PATIENT CONNECTION AND LOOKED LIKE CUTS/SLITS IN THE TUBING. THIS WAS IDENTIFIED PRIOR TO PATIENT CONNECTION 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 24345484 ↗
• MalfunctionJan 29, 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 24214601 ↗
• MalfunctionJan 29, 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 DWELL FOUR OF FIVE 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) INSTRUCTED THE PATIENT TO CLOSE ALL CLAMPS, REMOVE THE CASSETTE, AND 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 24211104 ↗
• MalfunctionJan 27, 2026Component Missing

  IT WAS REPORTED THAT THE PULL RING CAP WAS MISSING FROM AN UNSPECIFIED LINE OF THE HOMECHOICE CASSETTE. THIS WAS IDENTIFIED AFTER OPENING THE PACKAGING IN 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 24190907 ↗
• MalfunctionJan 22, 2026Fluid/Blood Leak

  IT WAS REPORTED THAT LEAKS WERE OBSERVED IN AN UNSPECIFIED QUANTITY OF HOMECHOICE DISPOSABLE CASSETTE SETS. THIS WAS FURTHER DESCRIBED AS ¿WHEN PRIMING SOLUTION WITH CASSETTE SOLUTION LEAKS ARE OBSERVED BY THE BOX AREA¿. THIS OCCURRED WITH ¿MULTIPLE CASSETTES¿ DURING SETUP OF THE DEVICES FOR PERITONEAL DIALYSIS (PD) 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 24147222 ↗
• MalfunctionJan 20, 2026Fluid/Blood Leak

  IT WAS REPORTED THAT A HOMECHOICE CASSETTE LEAKED FROM AN UNSPECIFIED LOCATION. THIS OCCURRED DURING FILL OF PERITONEAL DIALYSIS THERAPY. THE PATIENT NOTICED A FEW DROPS FROM THE GASKET OF THE CYCLER. RENAL THERAPY SERVICES (RTS) ADVISED TO END THERAPY AND ASSISTED THE PATIENT WITH REMOVING THE SUPPLIES. 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 24117660 ↗
• MalfunctionJan 13, 2026Loose 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 DRAIN TWO OF FOUR OF PERITONEAL DIALYSIS THERAPY. DURING TROUBLESHOOTING, IT WAS REPORTED THAT THERE WAS A LOOSE CONNECTION BETWEEN THE HOMECHOICE CASSETTE MINICAP TRANSFER SET THAT LED TO THIS ALARM. RENAL THERAPY SERVICES (RTS) ADVISED THE PATIENT 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 24059717 ↗
• MalfunctionJan 6, 2026Fluid/Blood Leak; Protective Measures Problem

  IT WAS REPORTED THAT A HOMECHOICE (HC) DEVICE EXPERIENCED A SYSTEM ERROR (SE) 2240 (AIR IN LINE/SET) ALARM. THE HOME PATIENT (HP) WAS CONNECTED AT THE TIME OF THE ALARM. THIS OCCURRED DURING DWELL FIVE OF FIVE OF PERITONEAL DIALYSIS THERAPY. DURING TROUBLESHOOTING, IT WAS REPORTED THAT A LEAK OCCURRED WHICH LED TO THIS ALARM; THE LEAK WAS OBSERVED ON THE FLOOR AND THE SOURCE WAS UNKNOWN. RENAL THERAPY SERVICES (RTS) ASSISTED THE HP TO END THE THERAPY SESSION, REMOVE THE CASSETTE AND PREPARE THE HC FOR THE NEXT THERAPY. RTS REVIEWED PROPER PROCEDURES PER THE USER MANUAL REVIEWED WITH THE HP. 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 23981505 ↗
• MalfunctionDec 22, 2025Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT AN UNSPECIFIED QUANTITY OF HOMECHOICE CASSETTE SETS LEAKED. THIS WAS DESCRIBED AS "THERE WAS A LEAKAGE OBSERVED AT THE PATIENT LINE END, WHERE THE BLUE CAP WAS". 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 23865842 ↗
• MalfunctionDec 17, 2025Fluid/Blood Leak; Protective Measures Problem; Fluid/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 DWELL OF PERITONEAL DIALYSIS THERAPY. DURING TROUBLESHOOTING, IT WAS REPORTED THAT THERE WAS A LEAK FROM AN UNSPECIFIED LOCATION. THERE WAS FLUID ON THE TABLE AND COMING FROM THE CYCLER. RENAL THERAPY SERVICES (RTS) ASSISTED THE PATIENT WITH ENDING THERAPY AND ADVISED TO DRAIN MANUALLY. 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 23829121 ↗
• InjuryDec 8, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A PERITONEAL DIALYSIS (PD) PATIENT FOUND A LEAK IN THE PATIENT LINE OF THE PERITONEAL DIALYSIS (PD) SET WITH CASSETTE. IT WAS REPORTED THAT THE PATIENT REPLACED THE SETUP AND RESTARTED THE THERAPY. SUBSEQUENTLY, THREE (3) DAYS AFTER THE EVENT, THE PATIENT WAS HOSPITALIZED FOR TWO (2) DAYS DUE TO "STAPH EPI PERITONITIS INFECTION". THE CAUSE OF THE PERITONITIS WAS NOT REPORTED. TREATMENT FOR THE EVENT WAS NOT REPORTED. PATIENT OUTCOME AND ACTION TAKEN WITH PD THERAPY WERE NOT REPORTED. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: Peritonitis

  MAUDE report 23746405 ↗
• MalfunctionDec 1, 2025Fluid/Blood Leak; Protective Measures Problem; Fluid/Blood Leak; Protective Measures Problem

  IT WAS REPORTED THAT A HOMECHOICE DEVICE EXPERIENCED A SYSTEM ERROR 2240 (AIR IN LINE/SET) ALARM. THE HOME PATIENT (HP) WAS CONNECTED AT THE TIME OF THE ALARM. THIS OCCURRED DURING DWELL FIVE OF FIVE OF PERITONEAL DIALYSIS (PD) THERAPY. DURING THE TROUBLESHOOTING, IT WAS REPORTED THAT THERE WAS A LEAK IN THE FINAL LINE OF THE HOMECHOICE CASSETTE THAT LED TO THIS ALARM. RENAL TECHNICAL SERVICES (RTS) ASSISTED THE HP TO CYCLE THE POWER AND CLEAR THE ALARM. THE HP WILL USE MANUAL SUPPLIES TO DO A MANUAL DRAIN. RTS ADVISED THE PATIENT TO CONTACT THEIR PD NURSE REGARDING MISSED 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 23681863 ↗
• MalfunctionDec 1, 2025Component Missing; Component Missing

  IT WAS REPORTED THAT TWO (2) UNITS OF HOMECHOICE CASSETTES WERE MISSING THE CAP/TIP PROTECTOR TO THE DRAIN LINE. THIS WAS DESCRIBED AS THERE WAS ¿NO PLUG ON THE TUBE THAT CONNECTS TO DRAIN BAGS. THE PLUG WAS NOT IN THE CASSETTE PACKAGE.¿ THIS OCCURRED DURING PREPARATION OF THE PRODUCT TO USE 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 23680955 ↗
• MalfunctionNov 20, 2025Fluid/Blood Leak; Material Split, Cut or Torn; Fluid/Blood Leak; Material Split, Cut or Torn

  IT WAS REPORTED THAT A HOMECHOICE CASSETTE LEAKED. THERE WAS LEAKAGE COMING FROM THE CASSETTE DOOR OF THE CYCLER. THIS OCCURRED WHILE PRIMING THE DEVICE FOR PERITONEAL DIALYSIS THERAPY. WHEN THE CASSETTE WAS REMOVED FROM THE CYCLER DOOR, A CUT ON THE PATIENT LINE WAS IDENTIFIED. 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 23606210 ↗
• MalfunctionOct 15, 2025Fluid/Blood Leak; Material Split, Cut or Torn; Fluid/Blood Leak; Material Split, Cut or Torn

  IT WAS REPORTED THAT A HOMECHOICE CASSETTE LEAKED. THE PATIENT NOTICED THEIR FLOOR WAS WET. 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 23295020 ↗
• MalfunctionSep 18, 2025Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT A HOMECHOICE CASSETTE LEAKED FROM AN UNSPECIFIED LOCATION WHICH RESULTED IN A WET CONTAMINATION. THERE WAS LEAKAGE FROM THE CASSETTE ONTO THE CYCLER AND FLOOR. THIS OCCURRED DURING SET UP 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 23085638 ↗
• MalfunctionSep 9, 2025Fluid/Blood Leak; Loose or Intermittent Connection; Protective Measures Problem; Fluid/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 DWELL FIVE OF FIVE OF PERITONEAL DIALYSIS (PD) THERAPY. DURING TROUBLESHOOTING, IT WAS REPORTED THAT THERE WAS A LOOSE CONNECTION BETWEEN THE FINAL LINE OF THE HOMECHOICE CASSETTE AND FINAL BAG WHICH RESULTED IN LEAK, THAT LED TO THIS ALARM. THERE WAS SOLUTION ON THE FLOOR. RENAL THERAPY SERVICES (RTS) GUIDED THE CAREGIVER TO END THE THERAPY AND ADVISED TO CONTACT THE NURSE REGARDING THE ISSUE. RTS REVIEWED PROPER PROCEDURES PER THE USER MANUAL REVIEWED WITH THE CAREGIVER. 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 23004798 ↗