HomeChoice PRO APD System 5C8310Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 00085412079165), received between Jan 11, 2018 and May 8, 2025 — classified as 1 death, 5 injuries, 1 malfunction.

The most frequently reported specific device problem is “Improper or Incorrect Procedure or Method” (3 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 18, 2026.

Most reported problems

Recent adverse event reports

The 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 8, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT AN AUTOMATED PERITONEAL DIALYSIS PATIENT PASSED AWAY AT HOME. IT WAS REPORTED THAT THE PATIENT WAS CONNECTED TO THE HOMECHOICE DEVICE AT THE TIME OF DEATH. THE CAUSE OF DEATH WAS NOT REPORTED. IT WAS NOT REPORTED IF THE PATIENT WAS HOSPITALIZED PRIOR TO DEATH. IT WAS NOT REPORTED IF AN AUTOPSY WAS PERFORMED. IT WAS NOT REPORTED IF PD THERAPY WAS ONGOING PRIOR TO OR AT THE TIME OF DEATH. NO ADDITIONAL INFORMATION WAS AVAILABLE.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 21988774 ↗
• InjuryMay 5, 2025Improper or Incorrect Procedure or Method; Improper or Incorrect Procedure or Method

  IT WAS REPORTED AN AUTOMATED PERITONEAL DIALYSIS (PD) PATIENT EXPERIENCED "HARD BREATHING, BLOATED, NAUSEA" DURING FILL ONE OF FOUR. THE PATIENT WAS CONNECTED TO THE HOMECHOICE PRO DEVICE AT THE TIME OF THE EVENT. RENAL THERAPY SERVICES (RTS) ASSISTED THE PATIENT TO DRAIN WHICH RELIEVED THE PATIENT SYMPTOMS, SPECIFIED AS "FELT RELIEF". TREATMENT WAS STOPPED. RTS ADVISED THE PATIENT TO CONTACT THE PD NURSE REGARDING THE INCIDENT AND TO INFORM THEM THAT THE IDA WAS SET TO 0. THERE WAS NO REPORT OF A MEDICAL INTERVENTION ASSOCIATED WITH THIS EVENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: Abdominal Distention; Dyspnea; Nausea

  MAUDE report 21961068 ↗
• InjuryJan 16, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT AN AUTOMATED PERITONEAL DIALYSIS PATIENT EXPERIENCED A ¿PROBLEM TO BREATHE¿ AND THEY FELT BLOATED DURING DWELL 4 OF 4. THE PATIENT WAS CONNECTED TO THE HOMECHOICE DEVICE AT THE TIME OF THE EVENT. A MANUAL DRAIN WAS COMPLETED WITH A DRAIN VOLUME OF ML. THERE WAS NO REPORT OF A MEDICAL INTERVENTION ASSOCIATED WITH THIS EVENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: Abdominal Distention; Dyspnea

  MAUDE report 21174711 ↗
• InjuryNov 26, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT AN AUTOMATED PERITONEAL DIALYSIS PATIENT EXPERIENCED DIFFICULTY BREATHING DURING AN UNKNOWN PROCESS STEP. THE PATIENT WAS CONNECTED TO THE HOMECHOICE PRO DEVICE AT THE TIME OF THE EVENT. RENAL THERAPY SERVICES (RTS) ASSISTED THE PATIENT TO END THERAPY. RTS INITIATED A SWAP OF THE DEVICE AND CONTINUOUS AMBULATORY PERITONEAL DIALYSIS WAS DISCUSSED. THERE WAS NO REPORT OF A MEDICAL INTERVENTION ASSOCIATED WITH THIS EVENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: Dyspnea

  MAUDE report 20780324 ↗
• InjuryNov 8, 2022Improper or Incorrect Procedure or Method; Improper or Incorrect Procedure or Method

  IT WAS REPORTED AN AUTOMATED PERITONEAL DIALYSIS PATIENT EXPERIENCED SHORTNESS OF BREATH AND NAUSEA FEELING DURING FILL 1. THE PATIENT WAS CONNECTED TO THE HOMECHOICE PRO DEVICE AT THE TIME OF THE EVENTS. THE PATIENT PERFORMED A MANUAL FILL OF 1000 ML (FOUR HOURS BEFORE STARTING PD THERAPY) AND DID NOT PERFORM A MANUAL DRAIN. INITIAL DRAIN VOLUME WAS 511ML, MANUALLY FILLED 1000ML. FILLED 1880MLIN FILL 1, LFV 1000ML. RENAL THERAPY SERVICES ADVISED THE PATIENT TO FOLLOW UP WITH THE PD NURSE AS THE PATIENT HAD ALREADY DISCONNECTED AND STARTED DRAINING MANUALLY. THE PATIENT REPORTED THE SYMPTOMS WERE NOT PRESENT AT THE TIME OF THE CALL. FURTHER REPORTED THE PATIENT CONNECTED TO THE DEVICE WET AFTER MANUAL EXCHANGE. THE DEVICE WAS OPERATIONAL AND A SWAP WAS NOT NECESSARY. THERE WAS NO REPORT OF MEDICAL INTERVENTION ASSOCIATED WITH THIS EVENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: Dyspnea; Nausea

  MAUDE report 15751818 ↗
• InjuryMay 27, 2021Improper or Incorrect Procedure or Method; Improper or Incorrect Procedure or Method

  IT WAS REPORTED AN AUTOMATED PERITONEAL DIALYSIS PATIENT EXPERIENCED FEELING TOO FULL AND DIFFICULTY BREATHING DURING DWELL 1 OF 4. THE PATIENT WAS CONNECTED TO THE HOMECHOICE PRO DEVICE AT THE TIME OF THE EVENTS. RENAL THERAPY SERVICES (RTS) ASSISTED THE PATIENT TO MANUALLY DRAIN, THE DRAIN VOLUME WAS 2649 ML. THE PATIENT REPORTED DRAINING RELIEVED THE SYMPTOMS. RTS ASSISTED PATIENT IN ENDING THE THERAPY EARLY. THE PATIENT STATED THEY PERFORMED MANUAL FILL PRIOR TO THE START OF THERAPY OF 2000ML AND DRAINED 1453ML. THE PATIENT HAD BYPASSED THE LOW DRAIN VOLUME ALARM IN INITIAL DRAIN PHASE TO FILL 1. THE DEVICE WAS OPERATIONAL, AND A SWAP WAS NOT NECESSARY. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: Abdominal Distention; Dyspnea

  MAUDE report 11898132 ↗
• DeathJan 11, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AN AUTOMATED PERITONEAL DIALYSIS PATIENT PASSED AWAY. THE CAUSE OF DEATH WAS NOT REPORTED. IT WAS NOT REPORTED IF THE PATIENT WAS HOSPITALIZED PRIOR TO DEATH. IT WAS NOT REPORTED IF AN AUTOPSY WAS PERFORMED. IT WAS NOT REPORTED IF THERAPY WAS ONGOING PRIOR TO DEATH OR IF THE PATIENT WAS PERFORMING THERAPY AT THE TIME OF DEATH. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: Death

  MAUDE report 7182173 ↗