INTERGRATED APD SET L5C4531Recalls & reported problems

Summary

The FDA's MAUDE database contains 811 adverse event reports that list this exact device (DI 00085412090078), received between Dec 23, 2017 and Jun 25, 2026 — classified as 9 injuries, 802 malfunctions.

The most frequently reported specific device problem is “Fluid/Blood Leak” (466 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 811 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 25, 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 THREE OF FIVE OF PERITONEAL DIALYSIS THERAPY. DURING TROUBLESHOOTING, IT WAS REPORTED THAT THERE WAS A LEAK BETWEEN THE SUPPLY LINE OF THE HOMECHOICE CASSETTE AND THE SUPPLY BAG THAT LED TO THIS ALARM. RENAL THERAPY SERVICES (RTS) ADVISED THE PATIENT TO REMOVE THE CASSETTE, DRAIN WITH MANUAL SUPPLIES, 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 25619845 ↗
• MalfunctionJun 17, 2026Crack; Fluid/Blood Leak

  IT WAS REPORTED THAT THERE WAS A CRACK IN THE PATIENT LINE OF A HOMECHOICE CASSETTE WHICH CAUSED A LEAK; DESCRIBED AS "THE CRACK IS IN THE MIDDLE OF THE PATIENT LINE, LESS THAN HALF AN INCH". THIS WAS IDENTIFIED DURING DRAIN FIVE OF FIVE OF AUTOMATED PERITONEAL DIALYSIS (PD) THERAPY. RENAL THERAPY SERVICES (RTS) INSTRUCTED THE HOME PATIENT (HP) TO DISCONNECT FROM THE MACHINE AND REMOVE THE SUPPLIES. RTS ADVISED THE HP TO DRAIN WITH MANUAL SUPPLIES AND TO CONTACT THEIR PD REGISTERED NURSE REGARDING THE 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 25535218 ↗
• MalfunctionJun 8, 2026Fluid/Blood Leak; Protective Measures Problem

  IT WAS REPORTED THAT A HOMECHOICE DEVICE EXPERIENCED A SYSTEM ERROR 2267 (AIR IN LINE/SET) ALARM. THE PATIENT WAS CONNECTED AT THE TIME OF THE ALARM. THIS OCCURRED DURING DWELL ONE OF FOUR OF (B)(6). DURING TROUBLESHOOTING, IT WAS REPORTED THAT THERE WAS A LEAK FROM AN UNSPECIFIED LOCATION THAT LED TO THIS ALARM. THERE WAS SOLUTION COMING OUT OF THE CYCLER CASSETTE DOOR. RENAL THERAPY SERVICES (RTS) ADVISED DISCONNECTING AND REMOVE 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 25430425 ↗
• MalfunctionJun 2, 2026Device Contamination with Chemical or Other Material

  IT WAS REPORTED THAT THERE WAS A FOREIGN OBJECT INSIDE THE PATIENT LINE OF 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 25360830 ↗
• MalfunctionJun 1, 2026Material Split, Cut or Torn

  IT WAS REPORTED THAT THERE WAS A SLICE/CUT IN THE PATIENT LINE OF AN UNSPECIFIED QUANTITY OF HOMECHOICE CASSETTES. THIS WAS IDENTIFIED DURING PRIMING 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 25351303 ↗
• MalfunctionMay 29, 2026Disconnection; 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 THREE OF FOUR OF PERITONEAL DIALYSIS THERAPY. DURING TROUBLESHOOTING, IT WAS REPORTED THAT THERE WAS A DISCONNECTION BETWEEN THE SUPPLY LINE OF THE HOMECHOICE CASSETTE AND THE SUPPLY BAG THAT LED TO THIS ALARM. RENAL THERAPY SERVICES (RTS) ADVISED THE PATIENT TO DRAIN WITH MANUAL SUPPLIES 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 25337672 ↗
• MalfunctionMay 27, 2026Break

  IT WAS REPORTED THAT CASSETTE SHEETING OF FIVE (5) HOMECHOICE CASSETTES WERE NOT SEALED. THIS WAS IDENTIFIED DURING SETUP OF THE DEVICES FOR PERITONEAL DIALYSIS THERAPY. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25302145 ↗
• MalfunctionMay 21, 2026Device Alarm System; Fluid/Blood Leak

  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 OF PERITONEAL DIALYSIS THERAPY. DURING TROUBLESHOOTING, IT WAS REPORTED THAT THERE WAS A LEAK FROM AN UNSPECIFIED LOCATION THAT LED TO THIS ALARM. THE PATIENT SAW FLUID ON THE TABLE WHERE THE CYCLER WAS LOCATED. RENAL THERAPY SERVICES (RTS) ADVISED THE PATIENT TO REMOVE 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 25240490 ↗
• MalfunctionMay 19, 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 FOUR OF FOUR OF PERITONEAL DIALYSIS THERAPY. DURING TROUBLESHOOTING, IT WAS REPORTED THAT THERE WAS A LEAK FROM AN UNSPECIFIED LOCATION THAT LED TO THIS ALARM. THERE WAS SOLUTION ON THE TABLE. RENAL THERAPY SERVICES (RTS) ADVISED THE PATIENT TO REMOVE THE CASSETTE AND END THERAPY AND TO DRAIN WITH MANUAL 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 25221503 ↗
• MalfunctionMay 14, 2026Component Missing

  IT WAS REPORTED THAT THE PULL RING CAP ON THE DRAIN LINE OF THE HOMECHOICE CASSETTE WAS MISSING. THIS WAS IDENTIFIED BEFORE OPENING THE PACKAGING. 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 25174794 ↗
• MalfunctionMay 13, 2026Device Contamination with Chemical or Other Material

  IT WAS REPORTED THAT THERE WAS PARTICULATE MATTER INSIDE ONE OF THE LINES OF THE HOMECHOICE CASSETTE. THIS WAS IDENTIFIED 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 25164715 ↗
• InjuryMay 12, 2026Fluid/Blood Leak; Adverse Event Without Identified Device or Use Problem

  A PERITONEAL DIALYSIS (PD) PATIENT EXPERIENCED LEAKING FROM AN AUTOMATED PD SET WITH CASSETTE. THE EXACT LOCATION OF THE LEAK WAS UNKNOWN, BUT IT WAS REPORTED THAT HE TUBING WAS WET "WHERE THE TUBING COMES OUT OF THE CASSETTE". IT WAS REPORTED THAT THE PATIENT EXPERIENCED PERITONITIS, MANIFESTED BY ABDOMINAL PAIN AND CLOUDY EFFLUENT. THE CAUSE WAS NOT REPORTED. IT WAS NOT REPORTED IF THE PATIENT WAS HOSPITALIZED FOR THE EVENT. THE PATIENT WAS TREATED WITH VANCOMYCIN AND CEFTAZIDIME, "SWITCHING TO AMPICILLIN". IT WAS REPORTED THAT THE TRANSFER SET WAS CHANGED. AT THE TIME OF THIS REPORT, THE PATIENT OUTCOME AND ACTION TAKEN WITH PD THERAPY WERE NOT REPORTED, HOWEVER IT WAS REPORTED THAT THE PATIENT WAS "FEELING BETTER AND SYMPTOMS WERE GONE". NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: Abdominal Pain; Peritonitis

  MAUDE report 25153864 ↗
• MalfunctionMay 11, 2026Crack; Fluid/Blood Leak

  IT WAS REPORTED THAT THE TUBING OF A HOMECHOICE CASSETTE WAS CRACKED WHICH RESULTED IN A LEAK. THIS OCCURRED DURING SECOND DWELL 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 25142181 ↗
• MalfunctionMay 5, 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 THREE OF FOUR OF PERITONEAL DIALYSIS THERAPY. DURING TROUBLESHOOTING, IT WAS REPORTED THAT THERE WAS A LEAK FROM AN UNSPECIFIED LOCATION THAT LED TO THIS ALARM. THERE WAS SOLUTION UNDER THE CYCLER. RENAL THERAPY SERVICES (RTS) ADVISED THE PATIENT TO DISCONNECT ASEPTICALLY AND 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 25084884 ↗
• MalfunctionMay 1, 2026Loose or Intermittent Connection

  IT WAS REPORTED THAT THE PATIENT CONNECTOR ON THE HOMECHOICE CASSETTE WAS LOOSE. THE PATIENT WAS ABLE TO PULL ON IT AND IT CAME OFF WITHOUT DIFFICULTY. THIS WAS IDENTIFIED WHILE PRIMING 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 25056508 ↗
• MalfunctionApr 30, 2026Disconnection; 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 THREE OF FIVE OF PERITONEAL DIALYSIS THERAPY. DURING TROUBLESHOOTING, IT WAS REPORTED THAT THERE WAS A DISCONNECTION BETWEEN THE SUPPLY LINE OF THE HOMECHOICE CASSETTE AND THE SUPPLY BAG THAT LED TO THIS ALARM. RENAL THERAPY SERVICES (RTS) INSTRUCTED THE CAREGIVER TO CLOSE THE TRANSFER SET AND TO DISCONNECT THE PATIENT FROM THE CYCLER. RTS ADVISED THE CAREGIVER TO CONTACT THE NURSE REGARDING THE 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 25049734 ↗
• MalfunctionApr 29, 2026Break; Fluid/Blood Leak

  DURING THE SAMPLE EVALUATION OF A RETURNED HOMECHOICE AUTOMATED PD SET WITH CASSETTE, A BREAK IN THE CASSETTE WAS DISCOVERED WHICH RESULTED IN A LEAK. THE DEVICE HAD BEEN PREVIOUSLY USED IN SET UP 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 25028975 ↗
• MalfunctionApr 23, 2026Fluid/Blood Leak

  IT WAS REPORTED THAT A HOMECHOICE CASSETTE LEAKED FROM AN UNSPECIFIED LOCATION. THERE WAS A LEAK FROM THE RIGHT SIDE OF THE CASSETTE DOOR OF THE CYCLER. 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 24965260 ↗
• MalfunctionApr 16, 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 DWELL THREE 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 THAT LED TO THIS ALARM. RENAL THERAPY SERVICES (RTS) INSTRUCTED THE PATIENT TO DISCONNECT ASEPTICALLY. 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 24903763 ↗
• MalfunctionApr 16, 2026Disconnection

  IT WAS REPORTED THAT THE PATIENT LINE OF A HOMECHOICE CASSETTE ¿POPPED OFF.¿. 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 24896212 ↗
• MalfunctionApr 13, 2026Disconnection

  IT WAS REPORTED THAT THERE WAS AN UNSPECIFIED DISCONNECTION WITH A HOMECHOICE CASSETTE. 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 24858837 ↗
• MalfunctionApr 6, 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 DRAIN TWO OF FOUR OF PERITONEAL DIALYSIS THERAPY. DURING TROUBLESHOOTING, IT WAS REPORTED THAT THERE WAS A LEAK FROM THE HOMECHOICE CASSETTE THAT LED TO THIS ALARM. RENAL THERAPY SERVICES (RTS) ADVISED THE PATIENT TO DISCONNECT. WHEN THE PATIENT TOOK THE CASSETTE OUT OF THE CYCLER, THE CASSETTE HAD A COUPLE DROPS OF WATER. RTS ADVISED THE PATIENT 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 24793691 ↗
• MalfunctionApr 6, 2026Material Puncture/Hole

  IT WAS REPORTED THAT THERE WERE HOLES IN THE TUBING OF AN UNSPECIFIED QUANTITY OF HOMECHOICE CASSETTES. 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 24789079 ↗
• MalfunctionApr 1, 2026Fluid/Blood Leak

  IT WAS REPORTED THAT A HOMECHOICE CASSETTE LEAKED FROM AN UNSPECIFIED LOCATION. THERE WAS MOISTURE ON THE CYCLER AND FLUID WAS COMING OUT OF THE CYCLER DOOR. THIS OCCURRED DURING DWELL ONE OF THREE OF PERITONEAL DIALYSIS THERAPY. RENAL THERAPY SERVICES (RTS) DISCUSSED THE USE OF MANUAL SUPPLIES AND 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 24755012 ↗
• MalfunctionMar 30, 2026Crack; 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 DRAIN TWO OF FIVE OF PERITONEAL DIALYSIS THERAPY. DURING TROUBLESHOOTING, IT WAS REPORTED THAT THERE WERE TWO CRACKS IN THE PATIENT LINE OF THE HOMECHOICE CASSETTE WHICH RESULTED IN A LEAK THAT LED TO THIS ALARM. RENAL THERAPY SERVICES (RTS) ADVISED THE PATIENT TO END THERAPY AND START OVER WITH NEW 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 24713218 ↗