Amia Automated PD Set with Cassette 5C5479Recalls & reported problems

Summary

The FDA's MAUDE database contains 976 adverse event reports that list this exact device (DI 00085412153186), received between Jan 2, 2018 and Aug 6, 2026 — classified as 11 injuries, 965 malfunctions.

The most frequently reported specific device problem is “Fluid/Blood Leak” (308 reports).

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

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. Nov 15, 2023Class IIOpen, Classified

   There is to an increase in complaints related to failure alarms for Wet Cassette Integrity Test occurring on the Amia devices.

   Z-0550-2024 · Root cause: Process control · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 25 most recent of 976 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 6, 2026Fluid/Blood Leak

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50160022 ↗
• MalfunctionJul 20, 2026Connection Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25882912 ↗
• MalfunctionJul 14, 2026Connection Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25810865 ↗
• MalfunctionJul 2, 2026Connection Problem

  IT WAS REPORTED THAT THREE (3) AMIA CASSETTES HAD A CONNECTION ISSUE. THIS WAS DESCRIBED AS ¿2 -3 TIMES, THE AMIA CASSETTE DID NOT CONNECT TO MACHINE¿. THIS ISSUE 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 25695293 ↗
• MalfunctionJun 30, 2026Disconnection

  IT WAS REPORTED THAT THERE WAS A DISCONNECTION BETWEEN THE AMIA CASSETTE AND MINICAP TRANSFER SET. THIS OCCURRED 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 25664848 ↗
• MalfunctionJun 29, 2026Disconnection

  IT WAS REPORTED THAT THERE WAS A DISCONNECTION ISSUE BETWEEN AN UNSPECIFIED QUANTITY OF AMIA CASSETTES AND A TRANSFER SET. THIS WAS OBSERVED DURING "MULTIPLE PROCESS STEPS" OF 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 25659008 ↗
• MalfunctionJun 24, 2026Material Rupture

  IT WAS REPORTED THAT AN AMIA CASSETTE BURST DURING PRIMING 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 25607417 ↗
• MalfunctionMay 29, 2026Fluid/Blood Leak; Material Puncture/Hole

  IT WAS REPORTED THAT THERE WAS A HOLE IN THE AMIA CASSETTE WHICH RESULTED IN A LEAK. THERE WAS FLUID DRIPPING FROM THE AMIA CYCLER DOOR. THIS WAS IDENTIFIED DURING TRAINING FOR PERITONEAL DIALYSIS THERAPY. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25331688 ↗
• MalfunctionMay 29, 2026Connection Problem

  IT WAS REPORTED THAT THERE WAS AN UNSPECIFIED CONNECTION ISSUE WITH TWO (2) AMIA CASSETTES. THIS OCCURRED 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 25330951 ↗
• MalfunctionMay 28, 2026Break; Fluid/Blood Leak

  IT WAS REPORTED THAT THE CASSETTE SHEETING OF FIVE (5) AMIA CASSETTES WAS NOT SEALED PROPERLY, WHICH RESULTED IN A LEAK. THIS OCCURRED 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 25316514 ↗
• MalfunctionMay 20, 2026Fluid/Blood Leak

  IT WAS REPORTED THAT AN AMIA CASSETTE SET LEAKED FROM AN UNSPECIFIED LOCATION. THIS WAS OBSERVED DURING SETUP OF THE DEVICE FOR AUTOMATED PERITONEAL DIALYSIS (PD) THERAPY; DESCRIBED AS WHEN THE HOME PATIENT (HP) REMOVED THE SET FROM THE PD CYCLER, "THEY FOUND A LEAK FROM THE SET¿. THE HP WAS NOT CONNECTED AT THE TIME OF THE EVENT. TECHNICAL SERVICE REPRESENTATIVE ADVISED THE HOME PATIENT TO DRY THE GASKET OF THE PD CYCLER AND START 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 25231856 ↗
• MalfunctionMay 19, 2026Fluid/Blood Leak; Protective Measures Problem

  IT WAS REPORTED THAT AN AMIA DEVICE EXPERIENCED A LOW PRIORITY ALARM 30166. THE PATIENT WAS CONNECTED AT THE TIME OF THE ALARM. DURING TROUBLESHOOTING, IT WAS REPORTED THAT THERE WAS A LEAK FROM AN UNSPECIFIED LOCATION. THERE WAS SOLUTION ON THE FLOOR. 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 25219449 ↗
• MalfunctionMay 15, 2026Connection Problem

  IT WAS REPORTED THAT THERE WAS AN UNSPECIFIED CONNECTION ISSUE WITH AN UNSPECIFIED QUANTITY OF AMIA CASSETTES. THIS OCCURRED DURING SETUP 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 25183719 ↗
• MalfunctionMay 12, 2026Component Missing

  IT WAS REPORTED THAT THE PULL RING CAP ON THE PATIENT LINE OF THE AMIA CASSETTE WAS MISSING. THIS WAS IDENTIFIED DURING SETUP 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 25149085 ↗
• MalfunctionMay 7, 2026Fluid/Blood Leak; Material Puncture/Hole

  IT WAS REPORTED THAT THERE WAS A HOLE IN THE AMIA CASSETTE WHICH RESULTED IN A LEAK. THERE WAS SOLUTION DRIPPING FROM THE CYCLER DOOR. 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 25112017 ↗
• MalfunctionMay 5, 2026Fluid/Blood Leak

  IT WAS REPORTED THAT AN UNSPECIFIED QUANTITY OF AMIA CASSETTES LEAKED FROM MULTIPLE UNSPECIFIED LOCATIONS. THIS OCCURRED 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 25085047 ↗
• MalfunctionApr 30, 2026Break

  IT WAS REPORTED THAT AN UNSPECIFIED QUANTITY, STATED AS "AROUND SEVEN (7)" UNITS, OF AMIA CASSETTE SETS WERE FOUND, TO BE "BROKEN" AT UNSPECIFIED LOCATIONS. 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 25046129 ↗
• MalfunctionApr 29, 2026Device Contamination with Chemical or Other Material

  IT WAS REPORTED THAT THERE WAS PARTICULATE MATTER IN THE TUBING OF AN AMIA 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 25034127 ↗
• MalfunctionApr 24, 2026Fitting Problem

  IT WAS REPORTED THAT THERE WAS AN UNSPECIFIED CONNECTION ISSUE WITH AN AMIA CASSETTE. THE CASSETTE WAS NOT CONNECTING. 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 24982685 ↗
• MalfunctionApr 23, 2026Connection Problem

  IT WAS REPORTED THAT THERE WERE UNSPECIFIED CONNECTION/SEPARATION ISSUES WITH AN UNSPECIFIED QUANTITY OF AMIA CASSETTES. THIS OCCURRED DURING SETUP 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 24965889 ↗
• MalfunctionApr 15, 2026Fluid/Blood Leak

  IT WAS REPORTED THAT AN UNSPECIFIED QUANTITY OF AMIA CASSETTES LEAKED FROM AN UNSPECIFIED LOCATION. THIS OCCURRED 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 24885248 ↗
• MalfunctionApr 6, 2026Fluid/Blood Leak

  IT WAS REPORTED THAT THERE WAS A LEAK FROM THE PATIENT LINE OF THE AMIA 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 24789370 ↗
• MalfunctionApr 1, 2026Connection Problem

  IT WAS REPORTED THAT TWO (2) AMIA CASSETTES HAD UNSPECIFIED CONNECTION ISSUES. THIS OCCURRED 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 24753146 ↗
• MalfunctionMar 30, 2026Fluid/Blood Leak; Detachment of Device or Device Component

  IT WAS REPORTED THAT THE MEMBRANE WAS DETACHED FROM THE CARTRIDGE OF THE AMIA CASSETTE WHICH RESULTED IN A LEAK. THIS WAS IDENTIFIED AFTER USE OF THE DEVICE FOR PERITONEAL DIALYSIS THERAPY, WHEN THE CASSETTE WAS REMOVED FROM THE CYCLER. 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 24731550 ↗
• MalfunctionMar 30, 2026Fluid/Blood Leak

  IT WAS REPORTED THAT DURING USE OF AN AMIA CASSETTE, THERE WAS A LEAK FROM AN UNSPECIFIED LOCATION; FURTHER DESCRIBED AS A "DRASTIC LEAK". THIS OCCURRED DURING AUTOMATED PERITONEAL DIALYSIS (PD) THERAPY. THE HOME PATIENT ENDED THE THERAPY SESSION. 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 24731288 ↗