AMIA Automated PD Cycler 5C9320Recalls & reported problems

Summary

The FDA's MAUDE database contains 43 adverse event reports that list this exact device (DI 00085412490120), received between Mar 13, 2019 and Sep 22, 2026 — classified as 7 deaths, 21 injuries, 15 malfunctions.

The most frequently reported specific device problem is “Improper or Incorrect Procedure or Method” (10 reports).

8 other recalls cover devices cleared under the same FDA submission (K151525); 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.

Most reported problems

Recent adverse event reports

The 25 most recent of 43 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 22, 2026Device Alarm System

  It was reported that there was a High Priority Alarm 20198 on an Amia Automated PD System. The cycler door was open. This occurred while priming for peritoneal dialysis therapy. Continuous Ambulatory Peritoneal Dialysis was discussed with the patient. 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 50855690 ↗
• MalfunctionAug 19, 2026Device Alarm System

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50326571 ↗
• DeathMar 18, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PERITONEAL DIALYSIS PATIENT PASSED AWAY "DURING THERAPY" WHILE USING AN AMIA DEVICE. THE CAUSE OF DEATH WAS UNKNOWN. IT WAS REPORTED THAT THE PATIENT LOST CONSCIOUSNESS DURING THERAPY AND WAS SENT "TO THE INTENSIVE CARE UNIT (ICU) OF A HOSPITAL". THE PATIENT SUBSEQUENTLY PASSED AWAY THE NEXT DAY. IT WAS NOT REPORTED IF AN AUTOPSY WAS PERFORMED. IT WAS REPORTED THAT THE PATIENT "CODED WHILE CONNECTED TO THE MACHINE". IT WAS NOT REPORTED IF THE PATIENT WAS CONNECTED AT THE TIME OF DEATH. NO ADDITIONAL INFORMATION WAS AVAILABLE.

  Patient problems: Loss of consciousness

  MAUDE report 24630062 ↗
• InjuryFeb 25, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT AN AUTOMATED PERITONEAL DIALYSIS (APD) PATIENT MISSED TREATMENTS WHILE USING AN AMIA (APD) MACHINE "BECAUSE THE DEVICE WAS NOT FUNCTIONING PROPERLY AND HAD TO BE SHUT DOWN UNEXPECTEDLY". IT WAS REPORTED THAT THE PATIENT EXPERIENCED "BLOATING" AND ELEVATED POTASSIUM LEVELS. THE PATIENT WAS HOSPITALIZED FOR UNSPECIFIED TREATMENT DUE TO THE ELEVATED POTASSIUM LEVELS. PATIENT OUTCOME WAS NOT REPORTED. ACTION TAKEN WITH PD THERAPY WAS NOT REPORTED. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: Abdominal Distention; Hyperkalemia

  MAUDE report 24446931 ↗
• InjuryJul 14, 2025Improper or Incorrect Procedure or Method; Improper or Incorrect Procedure or Method

  IT WAS REPORTED AN AUTOMATED PERITONEAL DIALYSIS (PD) PATIENT EXPERIENCED DIFFICULTY WITH BREATHING DURING AN UNKNOWN PROCESS STEP. THE PATIENT WAS NOT CONNECTED TO THE AMIA DEVICE AT THE TIME OF THE EVENT. THERE WAS NO REPORT OF HOSPITALIZATION OR 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: Dyspnea

  MAUDE report 22501852 ↗
• InjuryJun 27, 2025Improper or Incorrect Procedure or Method; Improper or Incorrect Procedure or Method

  IT WAS REPORTED AN AUTOMATED PERITONEAL DIALYSIS (PD) PATIENT EXPERIENCED ¿OVERFILL" DURING AN UNKNOWN PROCESS STEP WHILE USING AN AMIA MACHINE. THE PATIENT WAS HOSPITALIZED FOR THE EVENT. TREATMENT WAS NOT REPORTED. 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: Increased Intra-Peritoneal Volume (IIPV)

  MAUDE report 22346512 ↗
• InjuryApr 17, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DURING AUTOMATED PERITONEAL DIALYSIS (PD) USING A AMIA AUTOMATED PD CYCLER, THE PATIENT EXPERIENCED BLOATEDNESS AND DIFFICULTY BREATHING. THE PATIENT WAS CONNECTED DURING THE TIME OF THE EVENT. IT WAS REPORTED THAT THE DEVICE WAS NOT DRAINING FOR THREE DAYS. THE PATIENT ATTEMPTED TO MANUALLY DRAIN, HOWEVER IT WAS REPORTED THAT "NOTHING WAS COMING OUT". THERE WAS NO REPORT OF MEDICAL INTERVENTION. 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 21853462 ↗
• MalfunctionOct 14, 2024Filling Problem; Filling Problem

  IT WAS REPORTED THAT AN AMIA AUTOMATED PD SYSTEM UNDERDELIVERED PERITONEAL DIALYSIS (PD) SOLUTION TO THE PATIENT. THIS ISSUE WAS FURTHER DESCRIBED AS, ¿MACHINE SEEMS NOT TO BE TAKING THE CORRECT AMOUNT OF SOLUTION, THERE WAS MUCH MORE FLUID REMAINING AT THE END OF THERAPY¿. THIS OCCURRED DURING AN UNSPECIFIED PROCESS STEP OF PERITONEAL DIALYSIS THERAPY. CONTINUOUS AMBULATORY PERITONEAL DIALYSIS WAS DISCUSSED. 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 20439725 ↗
• MalfunctionSep 26, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT PASSED AWAY. IT WAS NOT REPORTED IF THE PATIENT WAS CONNECTED TO THE DEVICE AT THE TIME OF DEATH. THE CAUSE OF DEATH WAS REPORTED AS CARDIAC ARREST. THE PATIENT WAS HOSPITALIZED ONE DAY PRIOR TO DEATH DUE TO CONGESTIVE HEART FAILURE. IT WAS REPORTED THAT THE PATIENT PRESENTED TO THE HOSPITAL WITH SYMPTOMS OF FLUID OVERLOAD. IT WAS REPORTED THAT A CODE WAS CALLED DUE TO CARDIAC ARREST/"PEA" (PULSELESS ELECTRICAL ACTIVITY) FROM CONGESTIVE HEART FAILURE. IT WAS REPORTED THAT AN AUTOPSY WAS NOT PERFORMED. IT WAS NOT REPORTED IF PD THERAPY WAS ONGOING PRIOR TO DEATH OR AT THE TIME OF DEATH. NO ADDITIONAL INFORMATION WAS AVAILABLE.

  Patient problems: Cardiac Arrest; Dyspnea; Heart Failure/Congestive Heart Failure; Increased Intra-Peritoneal Volume (IIPV)

  MAUDE report 20315079 ↗
• MalfunctionAug 27, 2024Protective Measures Problem; Protective Measures Problem

  IT WAS REPORTED THAT AN AMIA DEVICE EXPERIENCED A HIGH PRIORITY ALARM 20198. THE PATIENT WAS CONNECTED AT THE TIME OF THE ALARM. THIS OCCURRED DURING AN UNSPECIFIED PROCESS STEP OF PERITONEAL DIALYSIS THERAPY. DURING TROUBLESHOOTING, IT WAS REPORTED THAT THE DOOR OF THE AMIA DEVICE WAS OPENED. RENAL THERAPY SERVICES (RTS) ASSISTED THE HOME PATIENT (HP) TO START OVER WITH NEW SUPPLIES. RTS ADVISED THE HP TO CONTACT THEIR PERITONEAL DIALYSIS REGISTERED NURSE REGARDING THE ISSUE. RTS DISCUSSED CONTINUOUS AMBULATORY PERITONEAL DIALYSIS 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 20076799 ↗
• MalfunctionAug 13, 2024Protective Measures Problem; Protective Measures Problem

  DURING THE SAMPLE EVALUATION ON A RETURNED AMIA DEVICE, IT WAS DETERMINED THAT THE DEVICE HAD EXPERIENCED A HIGH PRIORITY ALARM 20198 (THIS ALARM WAS NOT INITIALLY REPORTED). THE PATIENT WAS NOT CONNECTED AT THE TIME OF THE ALARM. THIS OCCURRED DURING SET UP FOR AUTOMATED 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 19977600 ↗
• MalfunctionJul 16, 2024Material Twisted/Bent; Protective Measures Problem; Material Twisted/Bent; Protective Measures Problem

  IT WAS REPORTED THAT A HIGH PRIORITY 20198 ALARM (DOOR IS OPEN) OCCURRED ON AN AMIA AUTOMATED PD SYSTEM DURING DRAIN FOUR (4) OF FOUR (4) OF PERITONEAL DIALYSIS (PD) THERAPY. THIS WAS THE THIRD TIME THIS HAPPENED IN THE THREE WEEKS THEY HAD THE DEVICE AND ONE OF THE CLOSING BARS OF THE DOOR WAS BENT. THE PATIENT WAS CONNECTED AT THE TIME OF THE ALARM. DURING TROUBLESHOOTING, RENAL THERAPY SERVICES (RTS) HAD THE CAREGIVER (CG) PRESS THE AUDIO OFF AND CLOSE THE TRANSFER SET. RTS ASSISTED THE CG TO END THE TREATMENT EARLY. RTS ADVISED THE CAREGIVER TO CONTACT THE PATIENT¿S PD NURSE AND DISCUSSED CONTINUOUS AMBULATORY PERITONEAL DIALYSIS.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 19757121 ↗
• InjuryJul 8, 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 ¿ISSUES WITH BREATHING AND FEELING FULL¿ DURING AN UNKNOWN PROCESS STEP. THE PATIENT WAS CONNECTED TO THE AMIA DEVICE AT THE TIME OF THE EVENT. IT WAS REPORTED THAT THE PATIENT WAS IN THE HOSPITAL FOR AN UNSPECIFIED INDICATION AT THE TIME OF THE EVENT. THE PATIENT MANUALLY DRAINED AND ENDED THERAPY. 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 19697290 ↗
• InjuryJun 18, 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 VOMITING, BREATHING DIFFICULTIES AND "FEELING SOME PAIN ON THE CHEST" DURING DWELL. THE PATIENT WAS CONNECTED TO THE AMIA DEVICE AT THE TIME OF THE EVENTS. RENAL THERAPY SERVICES (RTS) ASKED THE CAREGIVER (CG) TO STOP THE DEVICE IMMEDIATELY AND THEN ASSISTED THE CG THROUGH THE STEPS TO PERFORM A MANUAL DRAIN UNTIL EMPTY, OR TO DRAIN AS MUCH AS POSSIBLE. RTS ALSO ENCOURAGED THE CG TO CONTACT THEIR PERITONEAL DIALYSIS REGISTERED NURSE OR PD CLINIC. IF THE CG WAS UNABLE TO CONTACT ANYONE, RTS RECOMMENDED TO TAKE THE PATIENT TO THE EMERGENCY ROOM. 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: Chest Pain; Dyspnea; Vomiting

  MAUDE report 19559539 ↗
• InjuryApr 22, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A PERITONEAL DIALYSIS (PD) PATIENT EXPERIENCED SHORTNESS OF BREATH DURING DIALYSIS. IT WAS FURTHER REPORTED THAT THE DEVICE "KEPT BEEPING" UNSPECIFIED ERROR MESSAGE AND IT WAS NOT ABLE TO BE RESOLVED BY THE NURSE. IT WAS REPORTED THAT THE PATIENT HAD A TOTAL OF "3500 INSTILLED BUT ONLY 500 CAME OUT". THE PATIENT COMPLAINED OF SHORTNESS OF BREATH AND DISCONNECTED HIMSELF FROM THE CYCLER AND MANUALLY DRAINED. THE PATIENT WAS NOT HOSPITALIZED AND NO TREATMENT WAS GIVEN. 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: Dyspnea

  MAUDE report 19159116 ↗
• MalfunctionApr 12, 2024Unintended Electrical Shock; Unintended Electrical Shock

  IT WAS REPORTED THAT AN AUTOMATED PERITONEAL DIALYSIS PATIENT EXPERIENCED AN ELECTRIC SHOCK FROM AN AMIA DEVICE. THE EVENT OCCURRED DURING AN UNKNOWN PROCESS STEP. IT WAS UNKNOWN IF THE PATIENT WAS CONNECTED TO THE DEVICE DURING THE TIME OF THE EVENT. ACCORDING TO THE NURSE ¿THE HOME PATIENT CONTACTED THEM AND STATED THEY WERE BEING SHOCKED BY THE DEVICE¿. THE NURSE REPORTED THEY ADVISED THE PATIENT TO STOP USING THE DEVICE. RENAL THERAPY SERVICES 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: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19098701 ↗
• MalfunctionApr 4, 2024Unintended Electrical Shock; Unintended Electrical Shock

  IT WAS REPORTED THAT A HOME PATIENT (HP) EXPERIENCED SHOCK WHEN CONNECTED TO THE AMIA CYCLER. THE PATIENT FELT A MICRO-ELECTRICAL CURRENT. THIS WAS DISCOVERED DURING AN UNKNOWN PROCESS STEP OF PERITONEAL DIALYSIS (PD) THERAPY. THERE WAS NO REPORT OF MEDICAL INTERVENTION ASSOCIATED WITH THIS EVENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19042244 ↗
• MalfunctionMar 4, 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 A DISTENDED ABDOMEN, FEELING TOO FULL, NAUSEA, VOMITING AND TROUBLE BREATHING DURING AN UNREPORTED PROCESS STEP OF PD THERAPY. THE PATIENT WAS CONNECTED TO THE AMIA DEVICE AT THE TIME OF THE EVENT. RENAL THERAPY SERVICES (RTS) ADVISED THE PATIENT TO INFORM THE REGISTERED NURSE OF MISSED THERAPY SINCE THE PATIENT DID NOT WANT TO PERFORM THERAPY "TONIGHT". 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: Abdominal Distention; Dyspnea; Nausea; Vomiting

  MAUDE report 18827596 ↗
• InjuryJan 23, 2024Improper or Incorrect Procedure or Method; Improper or Incorrect Procedure or Method

  IT WAS REPORTED AN AUTOMATED PERITONEAL DIALYSIS PATIENT WAS UNABLE TO BREATHE DURING AN UNKNOWN PROCESS STEP. THE PATIENT WAS CONNECTED TO THE AMIA DEVICE AT THE TIME OF THE EVENT. THE PATIENT REPORTED THE DEVICE WAS "NOT DRAINING ENOUGH SOLUTION OFF, AND IT WAS LEAVING AROUND 600 ML OR SO". ACCORDING TO THE REPORTER THE PATIENT THEN ¿PUTS IN 1400 ML, AND THEY COULD NOT BREATHE¿. THE PATIENT PERFORMED A MANUAL DRAIN, AND THE ISSUE WAS RESOLVED. RENAL THERAPY SERVICES 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 18567370 ↗
• InjuryNov 8, 2023Improper or Incorrect Procedure or Method; Improper or Incorrect Procedure or Method

  IT WAS REPORTED THAT AN AUTOMATED PERITONEAL DIALYSIS (PD) PATIENT EXPERIENCED OVERFULLNESS, DIFFICULTY BREATHING AND NAUSEA DURING FILL 1. THE PATIENT WAS CONNECTED TO THE AMIA DEVICE AT THE TIME OF THE EVENTS. REPORTEDLY, THESE SYMPTOMS IMPROVED AFTER DRAINING. POST-OPERATIVELY, THE PD PATIENT RETAINED A LOT OF FLUID AND WAS NOT ABLE TO HANDLE THE STANDARD FILL VOLUME (2100ML). RENAL THERAPY SERVICES ADVISED THE CAREGIVER TO CONTACT THE PD NURSE TO HAVE THE THERAPY LOOKED AT, WHERE THE DEVICE FILLED, THE CORRECT AMOUNT OF EACH FILL AND NORMAL DRAIN AMOUNT. THE DEVICE WAS OPERATIONAL, AND A SWAP WAS NOT NECESSARY. THERE WAS NO MEDICAL INTERVENTION ASSOCIATED WITH THIS EVENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: Abdominal Distention; Dyspnea; Nausea

  MAUDE report 18094889 ↗
• InjuryOct 16, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED ABDOMINAL PAIN, DIFFICULTY BREATHING, AND FEELING VERY FULL. THE PATIENT WAS CONNECTED FOR PERITONEAL DIALYSIS (PD) THERAPY WITH AN AMIA CYCLER AT THE TIME OF THIS EVENT. THE PATIENT WAS NOT HOSPITALIZED FOR THIS EVENT. TO RESOLVE THIS ISSUE, A PARTIAL DRAIN WAS PERFORMED, AND THE PATIENT¿S SYMPTOMS WERE RELIEVED. AT THE TIME OF THIS REPORT, THE PATIENT STOPPED PD THERAPY WITH THE AMIA CYCLER AND PERFORMED CONTINUOUS AMBULATORY PERITONEAL DIALYSIS. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: Abdominal Distention; Abdominal Pain; Dyspnea

  MAUDE report 17941411 ↗
• InjuryOct 2, 2023Improper or Incorrect Procedure or Method; Improper or Incorrect Procedure or Method

  IT WAS REPORTED THE PATIENT EXPERIENCED FULLNESS, STOMACH TIGHTNESS, AND SHORTNESS OF BREATH. THE PATIENT WAS CONNECTED FOR PERITONEAL DIALYSIS (PD) THERAPY AT THE TIME OF THIS EVENT. DURING TROUBLESHOOTING, IT WAS DETERMINED THAT THE ESTIMATED NIGHT ULTRAFILTRATION (UF) SETTING WAS TOO LOW. THE PATIENT WOULD RAISE THE BED SLIGHTLY TO HELP WITH DRAIN SPEED IN THE MEANTIME AND WOULD SIT UP DURING THE EXTRA DRAIN REQUIRED TO DRAIN ALL REMAINING UF MORE EFFICIENTLY. AT THE TIME OF THIS REPORT, PD THERAPY WAS ONGOING. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: Abdominal Distention; Abdominal Pain; Dyspnea

  MAUDE report 17852847 ↗
• MalfunctionAug 18, 2023Fire; Fire

  IT WAS REPORTED AN AMIA AUTOMATED PD SYSTEM CAUGHT ON FIRE. THE PATIENT WAS CONNECTED AT THE TIME HOWEVER, IT WAS NOT SPECIFIED WHAT PROCESS STEP OF PERITONEAL DIALYSIS THERAPY THE EVENT OCCURRED. THE PATIENT WAS IN A CAMPER, AND IT WAS NOT REPORTED IF THE OUTLET WAS GROUNDED (OR IF THE UNIT WAS PLUGGED INTO A GENERATOR, 30AMP, OR 50AMP OUTLET). RENAL THERAPY SERVICES (RTS) INITIATED A SWAP OF THE DEVICE AND CONTINUOUS AMBULATORY PERITONEAL DIALYSIS WAS DISCUSSED. 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 17572818 ↗
• MalfunctionAug 17, 2023Fire; Fire

  IT WAS REPORTED AN AMIA AUTOMATED PD SYSTEM CAUGHT ON FIRE. THE PATIENT WAS CONNECTED AT THE TIME HOWEVER, IT WAS NOT SPECIFIED WHAT PROCESS STEP OF PERITONEAL DIALYSIS THERAPY THE EVENT OCCURRED. THE PATIENT WAS IN A CAMPER, AND IT WAS NOT REPORTED IF THE OUTLET WAS GROUNDED (OR IF THE UNIT WAS PLUGGED INTO A GENERATOR, 30AMP, OR 50AMP OUTLET). RENAL THERAPY SERVICES (RTS) INITIATED A SWAP OF THE DEVICE AND CONTINUOUS AMBULATORY PERITONEAL DIALYSIS WAS DISCUSSED. 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 17565795 ↗
• InjuryAug 10, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A STUDY REPORTED AN AUTOMATED PERITONEAL DIALYSIS (PD) PATIENT EXPERIENCED VOLUME OVERLOAD (NO FURTHER DETAILS). THE CAUSE OF THE EVENT WAS NOT REPORTED. PERITONITIS. IT WAS REPORTED THE PATIENT WAS HOSPITALIZED FOR THE EVENT. TREATMENT, PATIENT OUTCOMES AND ACTION TAKEN WITH PD THERAPY WERE NOT REPORTED. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: Insufficient Information

  MAUDE report 17498961 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K151525. One submission often covers many models, so check the product and lot details in each record.

• Z-0550-2024 · Nov 15, 2023 · Open, Classified
  Baxter Amia Automated Peritoneal Dialysis (APD) Cycler Set, REF 5C5479
• Z-2174-2021 · Jun 30, 2021 · Terminated
  Kaguya Automated Peritoneal Dialysis System
• Z-2173-2021 · Jun 30, 2021 · Terminated
  Sharesource Connectivity Platform for Use with the Amia Automated PD System
• Z-0849-2019 · Dec 11, 2018 · Terminated
  AMIA Automated Peritoneal Dialysis System Product Usage: It is intended for automatic control of dialysate solution exchanges in the treatment of adult renal failure patients
• Z-0850-2019 · Dec 11, 2018 · Terminated
  Kaguya Automated Peritoneal Dialysis System Product Usage: It is intended for automatic control of dialysate solution exchanges in the treatment of adult renal failure patients
• Z-2597-2018 · Jul 12, 2018 · Terminated
  power cord for: (a) AMIA Automated PD Cycler, Product Code: 5C9320; (b) Kaguya PD System, Product Code: T5C8500 (Japanese distribution only)
• Z-3133-2017 · Sep 1, 2017 · Terminated
  Baxter Amia Automated Peritoneal Dialysis Set with Cassette, REF 5C5479
• Z-1565-2016 · Feb 16, 2016 · Terminated
  Automated peritoneal dialysis (APD) cycler