Alaris C20025Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 10885403235504), received between Feb 24, 2019 and Oct 17, 2022 — classified as 1 injury, 7 malfunctions.

The most frequently reported specific device problem is “Break” (2 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 16, 2026.

Most reported problems

Recent adverse event reports

The 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• MalfunctionOct 17, 2022Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT THE BD 8IN EXTENSION SET EXPERIENCED A DEFECTIVE TUBING CLAMP. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: BD EXTENSION SET CONNECTED TO 18G PERIPHERAL IV, FLUSHED EASILY, POSITIVE BLOOD RETURN. CONNECTED TO CT CONTRAST TUBING. DURING SALINE FLUSH PRE-CONTRAST ADMINISTRATION, CLAMP OPEN, EXTENSION BURST APART AT CONNECTION OF CT CONTRAST TUBING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15615628 ↗
• MalfunctionSep 5, 2019Separation Problem; Separation Problem

  IT WAS REPORTED THAT THE T-CONNECTOR RUPTURED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8967218 ↗
• MalfunctionSep 5, 2019Separation Problem; Separation Problem

  IT WAS REPORTED THAT THE T-CONNECTOR RUPTURED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8967216 ↗
• InjuryMay 28, 2019Break; Fluid/Blood Leak; Break; Fluid/Blood Leak

  IT WAS REPORTED THAT A T-CONNECTOR "RUPTURED" DURING OMNIPAQUE 350 CONTRAST ADMINISTRATION DURING A CT SCAN. THE TUBING SET LEAKED NEAR THE CONNECTION SITE AT THE END CLOSEST TO THE PATIENT WITH SOME BLOOD LOSS. THE SPLIT IN THE TUBING WAS APPROXIMATELY 1CM LONG. THE HIGHEST PRESSURE RECORDED ON THE OMNIPAQUE WAS 220PSI; HIGHEST FLOW RATE RECORDED: 2.5ML/SEC. THE PATIENT WAS INITIALLY COMPLETING THE CT SCAN WHILE ASLEEP HOWEVER DUE TO THE EVENT AND PROLONGED TIME TO CHANGE THE TUBING, THE PATIENT WOKE UP AND SUBSEQUENTLY REQUIRED ADDITIONAL SEDATION TO COMPLETE THE IMAGING. THERE WAS NO LASTING EFFECT TO THE PATIENT.

  Patient problems: Inadequate Pain Relief

  MAUDE report 8645796 ↗
• MalfunctionMay 16, 2019Break; Fluid/Blood Leak; Break; Fluid/Blood Leak

  IT WAS REPORTED THAT A T-CONNECTOR RUPTURED DURING CONTRAST ADMINISTRATION WHILE CONNECTED TO A PATIENT DURING A CT SCAN. THE TUBING SET RUPTURED IN THE CENTER OF THE TUBING CREATING SOME BLOOD LOSS. THE RUPTURE WAS APPROXIMATELY 1.5CM LONG. THEY WERE ADMINISTERING OMNIPAQUE 350, HIGHEST PRESSURE RECORDED; 270/PSI, HIGHEST FLOW RATE RECORDED; 5.05ML/SEC. THERE WAS NO PATIENT HARM REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8615671 ↗
• MalfunctionMar 4, 2019Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  THE CUSTOMER REPORTED THAT THEY WORK IN CONJUNCTION WITH THE AMERICAN RED CROSS - WESTERN BLOOD SERVICES DIVISION IN PROVIDING APHERESIS THERAPY TO THEIR PATIENTS AND THAT THEY ARE CURRENTLY IN THE PROCESS OF CERTIFYING THEIR OWN APHERESIS UNIT. THE CUSTOMER REPORTED THAT THE OPTIA DEVICE THAT PERFORMS APHERESIS TREATMENT ALARMED FOR "AIR DETECTED IN CENTRIFUGE" WHILE USING THE EXTENSION TUBING SET. IT WAS FOUND THAT THE EXTENSION TUBING SET PULLED AIR FROM THE OUTSIDE INTO THE APHERESIS KIT AND CAUSED THE KIT/PLASMA EXCHANGE TO MALFUNCTION LEAVING THE NURSE WITH THE OPTION OF EITHER PERFORMING A RINSEBACK OR DISCONTINUING THE APHERESIS THERAPY. INSTEAD, THE NURSE REPLACED THE EXTENSION TUBING SET TO A DIFFERENT PRODUCT AND THE ISSUE WAS RESOLVED. THERE WAS NO PATIENT HARM.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8387743 ↗
• MalfunctionFeb 25, 2019Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  THE CUSTOMER REPORTED THAT THEY WORK IN CONJUNCTION WITH THE (B)(6) IN PROVIDING APHERESIS THERAPY TO THEIR PATIENTS AND THAT THEY ARE CURRENTLY IN THE PROCESS OF CERTIFYING THEIR OWN APHERESIS UNIT. THE CUSTOMER REPORTED THAT THE OPTIA DEVICE THAT PERFORMS APHERESIS TREATMENT ALARMED FOR "AIR DETECTED IN CENTRIFUGE" WHILE USING THE EXTENSION TUBING SET. IT WAS FOUND THAT THE EXTENSION TUBING SET PULLED AIR FROM THE OUTSIDE INTO THE APHERESIS KIT AND CAUSED THE KIT/PLASMA EXCHANGE TO MALFUNCTION LEAVING THE NURSE WITH THE OPTION OF EITHER PERFORMING A RINSEBACK OR TO DISCONTINUE THE APHERESIS THERAPY. INSTEAD, THE NURSE REPLACED THE EXTENSION TUBING SET TO A DIFFERENT PRODUCT AND THE ISSUE WAS RESOLVED. THERE WAS NO PATIENT HARM.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8368804 ↗
• MalfunctionFeb 24, 2019Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  THE CUSTOMER REPORTED THAT THEY WORK IN CONJUNCTION WITH THE AMERICAN RED CROSS - WESTERN BLOOD SERVICES DIVISION IN PROVIDING APHERESIS THERAPY TO THEIR PATIENTS AND THAT THEY ARE CURRENTLY IN THE PROCESS OF CERTIFYING THEIR OWN APHERESIS UNIT. THE CUSTOMER REPORTED THAT THE OPTIA DEVICE THAT PERFORMS APHERESIS TREATMENT ALARMED FOR "AIR DETECTED IN CENTRIFUGE" WHILE USING THE EXTENSION TUBING SET. IT WAS FOUND THAT THE EXTENSION TUBING SET PULLED AIR FROM THE OUTSIDE INTO THE APHERESIS KIT AND CAUSED THE KIT/PLASMA EXCHANGE TO MALFUNCTION LEAVING THE NURSE WITH THE OPTION OF EITHER PERFORMING A RINSE BACK OR TO DISCONTINUE THE APHERESIS THERAPY. INSTEAD, THE NURSE REPLACED THE EXTENSION TUBING SET TO A DIFFERENT PRODUCT AND THE ISSUE WAS RESOLVED. THERE WAS NO PATIENT HARM.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8364814 ↗