Homechoice Claria 5C6M40Recalls & reported problems

Summary

The FDA's MAUDE database contains 23 adverse event reports that list this exact device (DI 00085412676463), received between Mar 17, 2022 and Jul 29, 2026 — classified as 18 injuries, 5 malfunctions.

The most frequently reported specific device problem is “Improper or Incorrect Procedure or Method” (12 reports).

1 FDA recall record name this device's identifier, 1 still open.

1 other recall cover devices cleared under the same FDA submission (K201867); they may or may not involve this specific model.

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.

Recalls naming this device

1. Feb 22, 2023Class IIOpen, Classified

   The electrical safety testing was not properly performed on the impacted devices and additional testing is required

   Z-1316-2023 · Root cause: Process design · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 23 most recent of 23 reports, in the reporter's own words as published by the FDA.

• InjuryJul 29, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that an automated peritoneal dialysis patient experienced back pain and breathing problems during last fill. The patient was connected to the HomeChoice Claria device at the time of the events. The patient reported that this was their first time performing therapy. Renal Therapy Services (RTS) attempted to assist the patient to manually drain; however, they pressed the wrong button. The device moved to close all clamps. RTS assisted the patient to end the therapy and remove the cassette. RTS then guided the patient to manually drain. The patient reported that they felt better after the drain; however, the pain stood. RTS requested patient to go to the emergency room and to contact the Peritoneal Dialysis nurse. There was no report of medical intervention associated with this event. At the time of this report, the patient outcome was not reported. No additional information is available.

  Patient problems: Dyspnea; Pain

  MAUDE report 50072906 ↗
• InjuryJun 12, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED AN AUTOMATED PERITONEAL DIALYSIS (APD) PATIENT USING HOMECHOICE CLARIA DEVICE EXPERIENCED "BLOATING, FEELING OVERLY FULL, AND DIFFICULTY BREATHING". THE PATIENT WAS NOT CONNECTED DURING THE TIME OF THE EVENT. THE PATIENT WENT TO THE HOSPITAL AND 3000 ML OF FLUID WAS DRAINED. THERE WAS NO REPORT OF THE PATIENT BEING ADMITTED. TREATMENT FOR THE EVENT WAS NOT REPORTED. THE RETURN OF THE DEVICE WAS INITIATED. PD THERAPY WAS ONGOING. AT THE TIME OF THIS REPORT, THE PATIENT OUTCOME WAS UNKNOWN. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: Abdominal Distention; Dyspnea

  MAUDE report 25488958 ↗
• InjuryMar 11, 2026Improper or Incorrect Procedure or Method

  IT WAS REPORTED AN AUTOMATED PERITONEAL DIALYSIS PATIENT EXPERIENCED "FEELING FULL AND BLOATED AND WAS HAVING BREATHING DIFFICULTY". THE PATIENT WAS CONNECTED TO THE HOMECHOICE CLARIA DEVICE AT THE TIME OF THE EVENT. RENAL THERAPY SERVICES (RTS) HAD PATIENT END THE THERAPY EARLY AND REMOVE SUPPLIES. IT WAS REPORTED THAT THE PATIENT WILL CONTACT PERITONEAL DIALYSIS REGISTERED NURSE (PDRN). RTS INITIATED THE SWAP OF THE DEVICE AND CONTINUOUS AMBULATORY PERITONEAL DIALYSIS (CAPD) WAS DISCUSSED. AT THE TIME OF THIS REPORT, THE PATIENT OUTCOME WAS NOT REPORTED. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: Abdominal Distention; Dyspnea

  MAUDE report 24575883 ↗
• InjuryFeb 10, 2026Improper or Incorrect Procedure or Method

  IT WAS REPORTED THAT AN AUTOMATED PERITONEAL DIALYSIS PATIENT EXPERIENCED OVERFILL, FEELING FULL AND DIFFICULTY BREATHING DURING DWELL 1 OF 4. THE PATIENT WAS CONNECTED TO THE HOMECHOICE CLARIA DEVICE AT THE TIME OF THE EVENTS. RENAL THERAPY SERVICES (RTS) ASSISTED THE PATIENT TO MANUALLY DRAIN. THE PATIENT REPORTED THEY "FEEL EMPTY AND A LOT BETTER". RTS ADVISED THE PATIENT TO CONTACT THE REGISTERED NURSE REGARDING FURTHER INSTRUCTIONS. THE CAREGIVER REPORTED THAT THE PATIENT HAS A FILL VOLUME OF 2000ML AND WHEN THE PATIENT CONNECTED TO MACHINE, ONLY 500ML WAS DRAINED. RTS REVIEWED THE PROGRAM WITH THE CAREGIVER. ACCORDING TO THE CAREGIVER, THE IDV WAS PROGRAMED TO 0ML. RTS ADVISED THE PATIENT AGAIN TO CONTACT PDRN BEFORE CONNECTING AGAIN TO THE MACHINE. THERE WAS NO REPORT OF MEDICAL INTERVENTION ASSOCIATED WITH THIS EVENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: Abdominal Distention; Dyspnea; Increased Intra-Peritoneal Volume (IIPV)

  MAUDE report 24309044 ↗
• MalfunctionJan 7, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT AN AUTOMATED PERITONEAL DIALYSIS PATIENT EXPERIENCED ABDOMINAL PAIN, OVERFILL, AND DIFFICULTY BREATHING DURING A DWELL 5/5. THE PATIENT WAS CONNECTED TO THE HOMECHOICE CLAIRA DEVICE AT THE TIME OF THE EVENTS. THE CAREGIVER REPORTED TO RENAL THERAPY SERVICES (RTS) THAT THEY NEEDED TO PERFORM A MANUAL DRAIN BECAUSE PATIENT DIDN´T FEEL GOOD. RTS ASSISTED THE CAREGIVER WITH THE MANUAL DRAIN. THE DRAIN VOLUME WAS MORE THAN 3368 ML. AFTER DRAINING, THE PATIENT REPORTED THEY FELT BETTER AND RTS ASSISTED WITH ENDING THERAPY. RTS INITIATED A SWAP OF THE DEVICE AND CONTINUOUS AMBULATORY PERITONEAL DIALYSIS WAS DISCUSSED. THERE WAS NO REPORT OF MEDICAL INTERVENTION ASSOCIATED WITH THIS EVENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: Abdominal Pain; Dyspnea

  MAUDE report 23994397 ↗
• InjuryDec 18, 2025Improper or Incorrect Procedure or Method; Improper or Incorrect Procedure or Method

  IT WAS REPORTED AN AUTOMATED PERITONEAL DIALYSIS PATIENT EXPERIENCED "OVERFILL" WHILE USING HOMECHOICE CLARIA DEVICE. IT WAS REPORTED THAT THE PATIENT "HAD OVER 1500ML AND MANAGED TO BYPASS BEFORE THE FIRST FILL IN THE TREATMENT WHICH CAUSED OVERFILL AND HAD OVER 3500ML PD FLUID IN THE STOMACH". THE PATIENT WAS HOSPITALIZED. TREATMENT WAS NOT REPORTED. ACTION TAKEN WITH PD THERAPY WAS NOT REPORTED. AT THE TIME OF THIS REPORT, THE PATIENT OUTCOME WAS NOT REPORTED. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: Increased Intra-Peritoneal Volume (IIPV)

  MAUDE report 23839994 ↗
• MalfunctionNov 6, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT AN AUTOMATED PERITONEAL DIALYSIS (PD) PATIENT EXPERIENCED FEELINGS OF BEING BLOATED, DIFFICULTY BREATHING AND NAUSEA DURING DWELL 1 OF 5. THE PATIENT WAS CONNECTED TO THE HOMECHOICE CLARIA DEVICE AT THE TIME OF THE EVENTS. THE PATIENT ENDED THERAPY AND PERFORMED A MANUAL DRAIN. ACCORDING TO THE PATIENT, DRAINING RELIEVED THE SYMPTOMS AND THEY WERE FEELING BETTER. RENAL THERAPY SERVICES (RTS) REVIEWED THE THERAPY LOG AND THE PROGRAM. NO RECENT CHANGE IN THE PROGRAM WAS OBSERVED. RTS INITIATED THE SWAP OF THE DEVICE AND CONTINUOUS AMBULATORY PERITONEAL DIALYSIS (CAPD) WAS DISCUSSED. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: Abdominal Distention; Dyspnea; Nausea

  MAUDE report 23490284 ↗
• InjuryOct 29, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED AN AUTOMATED PERITONEAL DIALYSIS (PD) PATIENT USING A HOMECHOICE CLARIA EXPERIENCED "FEELING VERY FULL", ABDOMINAL TIGHTNESS AND "STRAINED WITH RESPIRATIONS" DURING AN UNSPECIFIED PROCESS STEP. THE PATIENT DISCONTINUED THERAPY AND PERFORMED A MANUAL DRAIN. IT WAS NOT REPORTED IF THE PATIENT WAS HOSPITALIZED. THERE WAS NO REPORT OF MEDICAL INTERVENTION ASSOCIATED WITH THIS EVENT. AT THE TIME OF THIS REPORT, THE PATIENT OUTCOME AND ACTION TAKEN WITH PD THERAPY WAS NOT REPORTED. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: Abdominal Distention; Dyspnea

  MAUDE report 23415135 ↗
• MalfunctionMay 19, 2025Improper or Incorrect Procedure or Method; Improper or Incorrect Procedure or Method

  IT WAS REPORTED AN AUTOMATED PERITONEAL DIALYSIS PATIENT EXPERIENCED "FULLNESS AND DIFFICULTY TO BREATH, A LOT OF PAIN" DURING DRAINING FOUR OF FOUR. THE PATIENT WAS CONNECTED TO THE HOMECHOICE (HC) CLARIA DEVICE AT THE TIME OF THE EVENTS. THERE WAS NO REPORT OF A MEDICAL INTERVENTION ASSOCIATED WITH THIS EVENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: Abdominal Distention; Dyspnea

  MAUDE report 22047595 ↗
• InjuryDec 11, 2024Improper or Incorrect Procedure or Method; Improper or Incorrect Procedure or Method

  IT WAS REPORTED THAT AN AUTOMATED PERITONEAL DIALYSIS PATIENT EXPERIENCED FEELING BLOATED AND COULD NOT BREATH PROPERLY DURING MULTIPLE STEPS OF THERAPY. THE PATIENT WAS CONNECTED TO THE HOMECHOICE CLARIA DEVICE AT THE TIME OF THE EVENTS. THE CAREGIVER REPORTED THAT THE PATIENT PERFORMED A MANUAL DRAIN AND THAT THE "PRESCRIPTION WAS CHANGED 2 WEEKS AGO". RENAL THERAPY SERVICES (RTS) ASSISTED THE CAREGIVER TO DISCONNECT THE PATIENT AND ADVISED THE CAREGIVER TO CONTACT THE PD NURSE. RTS INITIATED A SWAP OF THE DEVICE AND CONTINUOUS AMBULATORY PERITONEAL DIALYSIS WAS DISCUSSED. THERE WAS NO REPORT OF MEDICAL INTERVENTION ASSOCIATED WITH THIS EVENT. AT THE TIME OF THIS REPORT, THE PATIENT OUTCOME WAS NOT REPORTED. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: Abdominal Distention; Dyspnea

  MAUDE report 20903319 ↗
• InjuryNov 20, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED AN AUTOMATED PERITONEAL DIALYSIS PATIENT EXPERIENCED BLOATING DIFFICULTY BREATHING DURING DWELL 1 OF 4. THE PATIENT WAS CONNECTED TO THE HOMECHOICE CLARIA DEVICE AT THE TIME OF THE EVENTS. RENAL THERAPY SERVICES (RTS) ASSISTED THE PATIENT TO PERFORM A MANUAL DRAIN. THE TOTAL VOLUME REPORTED WAS 12,000ML. RTS ADVISED THE PATIENT TO CONTACT THE PD NURSE TO INFORM THEM OF THEIR SYMPTOMS AND THAT THEY MISSED PD 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: Abdominal Distention; Dyspnea

  MAUDE report 20734368 ↗
• InjurySep 20, 2024Improper or Incorrect Procedure or Method; Improper or Incorrect Procedure or Method

  IT WAS REPORTED AN AUTOMATED PERITONEAL DIALYSIS PATIENT EXPERIENCED FEELING FULL AND DIFFICULTY BREATHING DURING DWELL 1 OF 2. THE PATIENT WAS CONNECTED TO THE HOMECHOICE CLARIA AT THE TIME OF THE EVENTS. RENAL THERAPY SERVICES (RTS) ASSISTED THE PATIENT TO STOP THERAPY AND PERFORM A MANUAL DRAIN. THE PATIENT REPORTED THEY FELT BETTER AFTER DRAINING. IT WAS REPORTED THE DEVICE DRAINED 3928ML. RTS INITIATED A SWAP OF THE DEVICE AND CONTINUOUS AMBULATORY PERITONEAL DIALYSIS WAS DISCUSSED. THERE WAS NO REPORT OF MEDICAL INTERVENTION ASSOCIATED WITH THIS EVENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: Abdominal Distention; Dyspnea

  MAUDE report 20273112 ↗
• InjuryJul 18, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED AN AUTOMATED PERITONEAL DIALYSIS (PD) PATIENT EXPERIENCED "TROUBLE BREATHING" AND "FEELING BLOATED WITH ABDOMINAL PAIN" DURING THE FIRST FILL WHILE CONNECTED TO THE HOMECHOICE CLARIA DEVICE. THE PATIENT DRAIN MANUALLY AND FELT "BETTER". IT WAS NOT REPORTED IF THE PATIENT WAS HOSPITALIZED. THERE WAS NO REPORT OF MEDICAL INTERVENTION ASSOCIATED WITH THIS EVENT. AT THE TIME OF THIS REPORT, IT WAS REPORTED THAT THE PATIENT "RESTARTED WITH NEW SUPPLIES." NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: Abdominal Distention; Abdominal Pain; Dyspnea

  MAUDE report 19779125 ↗
• InjuryMay 23, 2024Improper or Incorrect Procedure or Method; Improper or Incorrect Procedure or Method

  IT WAS REPORTED AN AUTOMATED PERITONEAL DIALYSIS PATIENT EXPERIENCED "BEING VERY FULL" AND "GAINING" DURING THERAPY USING A HOMECHOICE (HC) CLARIA DEVICE. THE HP WAS CONNECTED DURING THE TIME OF THE EVENT. RENAL THERAPY SERVICES ASSISTED THE PATIENT WITH TROUBLE SHOOTING. THE PATIENT WENT TO THE HOSPITAL WHERE THERAPY WAS PERFORMED USING THE HOSPITAL DEVICE WITH NO ISSUES AND NO ALARMS. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: Abdominal Distention

  MAUDE report 19386799 ↗
• MalfunctionApr 25, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED AN AUTOMATED PERITONEAL DIALYSIS (PD) PATIENT EXPERIENCED AN UNSPECIFIED CARDIAC EVENT DURING AN UNKNOWN PROCESS STEP. THE PATIENT WAS CONNECTED TO THE HOMECHOICE CLARIA DEVICE AT THE TIME OF THE EVENT. IT WAS FURTHER REPORTED THAT THE CYCLER THE PATIENT WAS USING AT THE TIME WAS A TRAINING CYCLER AT THE CLINIC. IT WAS NOT REPORTED IF THE PATIENT WAS HOSPITALIZED. THERE WAS NO REPORT OF MEDICAL INTERVENTION ASSOCIATED WITH THIS EVENT. AT THE TIME OF THIS REPORT, THE PATIENT OUTCOME AND ACTION TAKEN WITH PD THERAPY WAS NOT REPORTED. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: Insufficient Information

  MAUDE report 19183554 ↗
• InjuryApr 25, 2024Improper or Incorrect Procedure or Method; Improper or Incorrect Procedure or Method

  IT WAS REPORTED AN AUTOMATED PERITONEAL DIALYSIS PATIENT EXPERIENCED SHORTNESS OF BREATH DURING A FILL. THE PATIENT WAS CONNECTED TO THE HOMECHOICE CLARIA DEVICE AT THE TIME OF THE EVENT. THE PATIENT REQUESTED TO END THERAPY AND WANTED TO DRAIN. RENAL THERAPY SERVICES (RTS) ASSISTED THE PATIENT WITH ENDING THERAPY AND A MANUAL DRAIN. THE FILL VOLUME WAS 1970 ML. RTS INITIATED A SWAP OF THE DEVICE AND DISCUSSED THE USE OF CONTINUOUS AMBULATORY PERITONEAL DIALYSIS. THERE WAS NO REPORT OF A MEDICAL INTERVENTION ASSOCIATED WITH THIS EVENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: Dyspnea

  MAUDE report 19183019 ↗
• InjuryJan 22, 2024Improper or Incorrect Procedure or Method; Improper or Incorrect Procedure or Method

  IT WAS REPORTED THAT AN AUTOMATED PERITONEAL DIALYSIS PATIENT EXPERIENCED FEELING BLOATED AND DIFFICULTY BREATHING DURING FILL 1 OF 7. THE PATIENT WAS CONNECTED TO THE HOMECHOICE CLARIA DEVICE AT THE TIME OF THE EVENTS. IT WAS ALSO REPORTED THAT THE PATIENT SUSPECTED THAT THEY WERE NOT DRAINING ENOUGH. RENAL THERAPY SERVICES (RTS) ASSISTED THE PATIENT TO PERFORM A MANUAL DRAIN WHICH RELIEVED THE SYMPTOMS. THE PATIENT REPORTED THEY WERE ¿FEELING GOOD¿ AND WERE ¿GOOD¿ TO CONTINUE THERAPY. RTS ADVISED THE PATIENT TO CONTACT THE REGISTERED NURSE. THE DEVICE WAS OPERATIONAL, AND A SWAP WAS NOT NECESSARY. THERE WAS NO REPORT OF A MEDICAL INTERVENTION ASSOCIATED WITH THIS EVENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: Abdominal Distention; Dyspnea

  MAUDE report 18553631 ↗
• InjuryDec 11, 2023Improper or Incorrect Procedure or Method; Improper or Incorrect Procedure or Method

  IT WAS REPORTED AN AUTOMATED PERITONEAL DIALYSIS (PD) PATIENT EXPERIENCED SIGNIFICANT ABDOMINAL PAIN" AND "FEELING UNWELL" DURING FILL 3 OF 3. THE PATIENT WAS CONNECTED TO THE HOMECHOICE CLARIA DEVICE AT THE TIME OF THE EVENT. THE CYCLER PERFORMED AN ¿INJECTION¿ AND AFTER THE INJECTION THE PATIENT EXPERIENCED THE ABDOMINAL PAIN. IT WAS FURTHER REPORTED THAT THE PATIENT PERFORMED TWO ¿STASIS SHUNT"; WENT INTO DRAINAGE; AND THEN COMPLETED THE PD TREATMENT. THE FOLLOWING NIGHT, THE PATIENT DID NOT PERFORM PD THERAPY BECAUSE THE PATIENT WAS NOT FEELING WELL. THE PATIENT PRESENTED TO THE HOSPITAL FOR AN ABDOMINAL CT SCAN. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: Abdominal Pain; Malaise

  MAUDE report 18307169 ↗
• InjuryNov 7, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED AN AUTOMATED PERITONEAL DIALYSIS PATIENT EXPERIENCED FEELING OVERFILLED, SWOLLEN ABDOMEN, DIFFICULTY BREATHING AND MOVING DURING AN UNKNOWN PROCESS STEP. THE PATIENT WAS CONNECTED TO THE HOMECHOICE CLARIA DEVICE AT THE TIME OF THE EVENTS. THE PATIENT STATED THAT FOR THE LAST WEEK THEY HAVE BEEN FEELING OVERFILLED; HOWEVER, THEY DID NOT REPORT IT TO THE PD RN. RENAL THERAPY SERVICES (RTS) ASSISTED THE PATIENT TO MANUALLY DRAIN, AND THE PATIENT STATED DRAINING HELPED. RTS INITIATED A SWAP OF THE DEVICE AND CONTINUOUS AMBULATORY PERITONEAL DIALYSIS WAS DISCUSSED. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: Abdominal Distention; Dyspnea; Movement Disorder; Swelling/ Edema

  MAUDE report 18088768 ↗
• InjuryAug 10, 2023Improper or Incorrect Procedure or Method; Improper or Incorrect Procedure or Method

  IT WAS REPORTED AN AUTOMATED PERITONEAL DIALYSIS (PD) PATIENT EXPERIENCED SYMPTOMS OF OVERFILL, BLOATING, BREATHING DIFFICULTY, BURPING, AND ABDOMINAL PAIN DURING DWELL 1 OF 4. THE PATIENT WAS CONNECTED TO THE HOMECHOICE CLARIA DEVICE AT THE TIME OF THE EVENTS. THE PATIENT REPORTED THE LAST THREE NIGHTS THEY HAD EXPERIENCED THE EVENTS. ACCORDING TO THE PATIENT THEY WERE OVERFILLED SO THEY CALLED THEIR PDRN AND WERE ADVISED TO CALL RENAL THERAPY SERVICES (RTS) TO HELP DRAIN. RTS ASSISTED THE CAREGIVER WITH PERFORMING A MANUAL DRAIN. IT WAS FURTHER REPORTED, THE PATIENT "FELT MUCH BETTER¿. RTS INITIATED A SWAP OF THE DEVICE AND CONTINUOUS AMBULATORY PERITONEAL DIALYSIS WAS DISCUSSED. THERE WAS NO REPORT OF MEDICAL INTERVENTION ASSOCIATED WITH THE EVENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: Abdominal Distention; Abdominal Pain; Dyspnea; Eructate

  MAUDE report 17499837 ↗
• MalfunctionAug 2, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED AN AUTOMATED PERITONEAL DIALYSIS (PD) PATIENT EXPERIENCED CARDIAC ARREST WHILE CONNECTED TO A HOMECHOICE CLARIA DEVICE. THE NURSE REPORTED THE CAREGIVER CALLED EMERGENCY MEDICAL SERVICES AND THE PATIENT WAS ¿EMERGENTLY DISCONNECTED¿ FOR TRANSPORT TO HOSPITAL. SUBSEQUENTLY, THE PATIENT PASSED AWAY. THE CAUSE OF DEATH WAS REPORTED AS CARDIAC ARREST. IT WAS REPORTED AN AUTOPSY IS BEING CONDUCTED AND AWAITING RESULTS. THE NURSE REPORTED THIS WAS THE FIRST TREATMENT SINCE BEING DISCHARGED FROM THE HOSPITAL FOR ANOTHER INDICATION. THE TREATMENT WAS REVIEWED BY THE PD NURSE, AND IT WAS NOTED THE PATIENT¿S INITIAL DRAIN WAS ONLY 48 ML. THE NURSE REPORTED THEY WERE UNSURE IF THE HOSPITAL DISCHARGED THE PATIENT WITH FLUID OR NOT. THERE WERE NO ISSUES REPORTED WITH THE DEVICE AND NO ALARMS WERE GENERATED. THE DEVICE WAS OPERATIONAL, AND A SWAP WAS NOT NECESSARY. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: Cardiac Arrest

  MAUDE report 17443478 ↗
• InjuryJul 21, 2023Improper or Incorrect Procedure or Method; Improper or Incorrect Procedure or Method

  IT WAS REPORTED AN AUTOMATED PERITONEAL DIALYSIS PATIENT EXPERIENCED ABDOMINAL PAIN, BACK PAIN, DIFFICULTY BREATHING, AND BLOATING DURING DWELL 1 OF 5. THE PATIENT WAS CONNECTED TO THE HOMECHOICE CLARIA AT THE TIME OF THE EVENTS. RENAL THERAPY SERVICES (RTS) ASSISTED THE PATIENT TO CYCLE POWER. THE PATIENT DID NOT VERIFY IF PATIENT LINE PRIMED TO THE TOP. THE PATIENT REPORTED THEY THOUGHT THE DEVICE DID NOT DRAIN THEM ENOUGH AND THAT WAS WHY THEY FEEL SO FULL. RTS ASSISTED THE PATIENT WITH MANUAL DRAINING AND THE PATIENT STATED THEY FELT MUCH BETTER AND RESUMED THERAPY. AFTER RESUMING THERAPY, THE PATIENT REPORTED THAT THEY WERE HAVING RIGHT SHOULDER PAIN. RTS ASSISTED THE PATIENT WITH ENDING THE THERAPY AND THE MANUAL DRAINING. RTS ADVISED THE PATIENT TO GET THE PATIENT ACTIVATION CODE FROM THE PD REGISTERED NURSE. RTS INITIATED A SWAP OF THE DEVICE AND CONTINUOUS AMBULATORY PERITONEAL DIALYSIS WAS DISCUSSED. THERE WAS NO REPORT OF MEDICAL INTERVENTION ASSOCIATED WITH THE EVENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: Abdominal Distention; Abdominal Pain; Dyspnea

  MAUDE report 17371540 ↗
• InjuryMar 17, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED AN AUTOMATED PERITONEAL DIALYSIS PATIENT FELT BLOATED AND HAD DIFFICULTY BREATHING DURING DWELL 1 OF 4. THE PATIENT WAS CONNECTED TO THE HOMECHOICE CLARIA DEVICE AT THE TIME OF THE EVENTS. THE THERAPY VOLUME WAS14500 ML, FILL VOLUME WAS 3000 ML, THE LAST FILL VOLUME WAS 2500ML AND THE INITIAL DRAIN ALARM WAS 0. RENAL THERAPY SERVICES (RTS) INSTRUCTED THE CAREGIVER TO IMMEDIATELY PRESS STOP AND ARROW DOWN TO PERFORM A MANUAL DRAIN. DRAINING RELIEVED SYMPTOMS. THE DRAIN VOLUME WAS 5782 ML. RTS HAD THE CAREGIVER PRESS STOP AND ARROW DOWN TO BYPASS, AFTER PRESSING ENTER THE DEVICE DISPLAYED DRAIN 1 OF 4. RTS INITIATED A SWAP OF THE DEVICE AND CONTINUOUS AMBULATORY PERITONEAL DIALYSIS WAS DISCUSSED. THERE WAS NO MEDICAL INTERVENTION ASSOCIATED WITH THIS EVENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: Abdominal Distention; Dyspnea

  MAUDE report 13791325 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K201867. One submission often covers many models, so check the product and lot details in each record.

• Z-0409-2026 · Aug 28, 2025 · Open, Classified
  Sharesource Connectivity Platform for Use with Homechoice Claria Product Code 5CGM01 software versions 7.13.3 (China), 8.13.2 (APAC and Korea), and 8.13.4 (US, EMEA, and LATAM)