Alaris C25012Recalls & reported problems

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 10885403235610), received between Apr 9, 2019 and Feb 20, 2025 — classified as 10 malfunctions.

The most frequently reported specific device problem is “Fluid/Blood Leak” (5 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 10 most recent of 10 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 20, 2025Defective Component; Defective Component

  NO ADDITIONAL INFORMATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21428719 ↗
• MalfunctionMar 12, 2023Excess Flow or Over-Infusion; Excess Flow or Over-Infusion

  IT WAS REPORTED THAT THE BD ALARIS EXTENSION SET EXPERIENCED UNDERINFUSION. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: BAG 1 HUNG ON (B)(6) 2023 AT 2007, TAKEN DOWN ON (B)(6) 2023 AT 0125- INFUSED 29HOURS- 5 HOURS OVER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16527253 ↗
• MalfunctionMar 12, 2023Volume Accuracy Problem; Volume Accuracy Problem

  IT WAS REPORTED THAT THE BD ALARIS EXTENSION SET EXPERIENCED UNDERINFUSION. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: NO ALARMS, THE BAGS ARE FILLED WITH AROUND 521ML, THEN ABOUT 40ISH ML OF OVERFILL. WE RUN THEM AT ABOUT 23-25ML/HR FOR 24HRS. A FEW BAGS A MONTH AGO RAN 5 AND 7 HOURS OVER! NO ALARMS, NO AIR IN LINE ALERTS. THE PUMP STATED IT INFUSED 740ML. WE FILLED THOSE BAGS OF SALINE DOWN IN PHARMACY TO TROUBLE SHOOT, WE COULDN¿T EVEN PUT THAT MUCH SALINE IN THE BAGS. WE HAD OUR BIOMED TEAM TROUBLESHOOT THE ALARIS PUMP AND IT WAS FOUND TO BE CALIBRATED PROPERLY. THIS IS THE ONLY OTHER STEP I CAN THINK OF. ¿ WAS THERE ANY IMPACT OR HARM DUE TO THE REPORTED ISSUE? CHEMOTHERAPY DID NOT INFUSE OVER ALLOTTED TIME OF 24 HOURS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16527232 ↗
• MalfunctionAug 4, 2022Material Separation; Material Separation

  IT WAS REPORTED THAT THE BD DEHP FREE 4 IN EXT SET W/ANTSPHN VLV DET SEPARATED DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THE ANTI SYPHON LINE CAME APART AT THE MIDDLE CONNECTION AND THE CHEMOTHERAPY LINE HIT THE GROUND.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15163372 ↗
• MalfunctionJun 7, 2021Complete Blockage; Restricted Flow rate; Complete Blockage; Restricted Flow rate

  IT WAS REPORTED THAT THE DEHP FREE 4 IN EXT SET W/ANTSPHN VLV DET WAS UNABLE TO INFUSE FLUIDS BEYOND THE ATTACHED ANTI-SIPHON SET DUE TO FLOW ISSUES/BLOCKAGE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "IV PUMP BEEPED INDICATING OCCLUSION. IV SITE INTACT, FLUSHING EASILY WITH NO OCCLUSION OR OBSTRUCTION NOTED. UNABLE TO INFUSE FLUIDS BEYOND THE ANTI-SIPHON EXTENSION SET WHICH HAD BEEN ATTACHED TO THE LINE. ATTEMPTED TO REMOVE ANTI-SIPHON SET BUT SAME HAD BECOME STUCK IN THE LINE."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11948038 ↗
• MalfunctionJan 8, 2020Disconnection; Fluid/Blood Leak; Disconnection; Fluid/Blood Leak

  IT WAS REPORTED THAT EXTENSION SET DOES NOT CONNECT CORRECTLY TO THE CLOSED SYSTEM DRUG TRANSFER DEVICE (CSTD) PHASEAL OPTIMA. IT WAS THEN NOTED THAT DISCONNECTIONS AND LEAKS HAVE OCCURRED WHILE INFUSING CHEMOTHERAPY BLINATUMOMAB. PHASEAL OPTIMA WAS REMOVED FROM THE TUBING SET-UP AND INFUSION WAS CONTINUED WITH NO FURTHER ISSUES. THERE WAS NO PATIENT HARM AND THERE WAS NO HARM TO HEALTHCARE PROVIDER.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9565156 ↗
• MalfunctionJun 10, 2019Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT THE ANTI-SIPHON VALVE LEAKED AT THE CONNECTION TO THE NON-PVC TUBING SET. THE ANTI-SIPHON VALVE WAS PRE-PRIMED WITH A RE-FILLED SYRINGE PRIOR TO CONNECTING IT TO THE TUBING SET.

  Patient problems: No Information

  MAUDE report 8685046 ↗
• MalfunctionJun 7, 2019Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT DURING A CHEMOTHERAPY INFUSION OF BLINCYTO INFUSING AT A RATE OF 10ML/HOUR THAT THE ANTI-SIPHON VALVE LEAKED AT CONNECTION TO THE NON-PVC TUBING SET APPROXIMATELY 16 HOURS AFTER THE INITIATION OF THE CHEMOTHERAPY INFUSION ON (B)(6) 2019. THE ANTI-SIPHON VALVE WAS PRE-PRIMED WITH A PRE-FILLED SYRINGE PRIOR TO CONNECTING IT TO THE TUBING SET.

  Patient problems: No Information

  MAUDE report 8679385 ↗
• MalfunctionApr 9, 2019Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT THE ANTI-SIPHON VALVE TUBING LEAKED WHILE INFUSING ETOPOSIDE. THE ADULT PATIENT REPORTED WETNESS THEN ON ASSESSMENT A SMALL AMOUNT OF SANGUINEOUS DRAINAGE WAS NOTED ON THE PATIENT'S BED SHEETS. TUBING WAS REPLACED AND THERE WAS NO HARM TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8496062 ↗
• MalfunctionApr 9, 2019Disconnection; Fluid/Blood Leak; Disconnection; Fluid/Blood Leak

  IT WAS REPORTED THAT THE ANTI-SIPHON VALVE TUBING LEAKED WHILE INFUSING ETOPOSIDE. THE TUBING DISCONNECTED FROM THE ADULT PATIENT'S PAC LINE WHICH CAUSED BLOOD TO BACKFLOW ONTO THE BED AND LINENS. CHEMOTHERAPY SPILL KIT WAS USED TO CLEAN UP BLOOD AND AREA. TUBING WAS REPLACED AND THE CHEMOTHERAPY RESTARTED. THERE WAS NO HARM.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8496061 ↗