ICU Medical CH3033Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00840619024109), received between Mar 5, 2019 and Feb 9, 2022 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Fluid/Blood Leak” (3 reports).

9 other recalls cover devices cleared under the same FDA submission (K173477); 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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 9, 2022Fluid/Blood Leak; Fluid/Blood Leak

  THE CUSTOMER REPORTED A ISSUE WITH 14" BIFUSE ADD-ON SET W/BAG SPIKE, SPIROS® W/RED CAP, VENTED CAP THAT DURING THE CHEMOTHERAPY TREATMENT, THE NURSE NOTICED AFTER THE PRIMING SOME DROPS LIKE BEADS ON THE TUBING AT THE Y CONNECTOR. THE DEVICE DID NOT LEAK WHEN PRIMED WITH PHYSIOLOGICAL SERUM. THE INFUSION LINE WAS CHANGED TO MAKE THE CHEMOTHERAPY PASS THROUGH CHECKING THAT THE SYSTEM IS INDEED OCCLUSIVE. THERE WAS CHEMOTHERAPY EXPOSURE FOR THE HEALTHCARE PROVIDER. THERE WAS PATIENT INVOLVEMENT AND NO REPORT OF AN ADVERSE EVENT OR HARM.

  Patient problems: Chemical Exposure; No Clinical Signs, Symptoms or Conditions

  MAUDE report 13497474 ↗
• MalfunctionMay 19, 2021Fluid/Blood Leak; Fluid/Blood Leak

  THE EVENT INVOLVED A 14" BIFUSE ADD-ON SET W/BAG SPIKE, SPIROS® W/RED CAP, VENTED CAP THAT THE CUSTOMER OBSERVED A LEAK OF MITOXANTRONE AT THE Y-TUBING 10 MINUTES AFTER THE START OF THE CHEMOTHERAPY. THERE WAS NO LEAK OBSERVED ON THE Y-TUBING DURING THE PREPARATION OF CHEMOTHERAPY. THE TUBING WAS CHANGED AND THE CHEMOTHERAPY REMAINING IN THE BAG WAS ADMINISTERED. THE CUSTOMER REPORTED THERE WAS INCOMPLETE CHEMOTHERAPY ADMINISTRATION WITH A LOSS OF 7 ML OF THE MITOXANTRONE. THE EVENT OCCURRED ON A PEDIATRIC UNIT AND THE PATIENT WAS HOSPITALIZED FOR CHEMOTHERAPY TREATMENT FOR ACUTE LYMPHOBLASTIC LEUKEMIA DISCOVERED IN (B)(6) 2020. THERE WERE NO PHYSICAL DEFECTS OBSERVED ON THE DEVICE. THERE WAS PATIENT INVOLVEMENT AND UNPROTECTED EXPOSURE TO CHEMOTHERAPY, HOWEVER, NO REPORT OF ADVERSE EVENT, NO NEGATIVE CONSEQUENCE FOR THE PATIENT, NO MEDICAL INTERVENTION NEEDED, AND NO DELAY IN THERAPY.

  Patient problems: Chemical Exposure; No Clinical Signs, Symptoms or Conditions

  MAUDE report 11851759 ↗
• MalfunctionMar 5, 2019Fluid/Blood Leak; Fluid/Blood Leak

  THE EVENT INVOLVED BIFUSE TUBING THAT LEAKED DROPS OF AN UNKNOWN CHEMOTHERAPY DRUG AND MADE CONTACT WITH THE PATIENT AND CAREGIVERS. THE DEVICE WAS CHANGED AND NO FURTHER PROBLEMS WERE ENCOUNTERED. THERE WAS PATIENT INVOLVEMENT AND A DELAY IN THERAPY, HOWEVER NO REPORTED MEDICAL OR SURGICAL INTERVENTION.

  Patient problems: Chemical Exposure

  MAUDE report 8391920 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K173477. One submission often covers many models, so check the product and lot details in each record.

• Z-3161-2026 · May 12, 2026 · Open, Classified
  IV Sets with drip chambers
• Z-3159-2026 · May 12, 2026 · Open, Classified
  Oncology sets with drip chambers
• Z-1578-2021 · Mar 16, 2021 · Open, Classified
  REF CH3011 30" (76 cm) Appx 3.3 mL, 20 Drop Admin Set w/Integrated ChemoClave Drip Chamber, Spiros w/Red Cap, Bag Hanger - Product Usage: provides access for the administration o
• Z-1576-2021 · Mar 16, 2021 · Open, Classified
  REF CH2020 20mL Syringe w/Spinning Spiros, Red Cap - Product Usage: provides access for the administration of fluids from a container to a patient s vascular system through the adm
• Z-1577-2021 · Mar 16, 2021 · Open, Classified
  REF CH2060 60mL Syringe w/Spinning Spiros, Red Cap - Product Usage: provides access for the administration of fluids from a container to a patient s vascular system through the adm
• Z-1579-2021 · Mar 16, 2021 · Open, Classified
  REF CH3020 40" (102 cm) Appx. 4.8 ml, 20 Drop Admin Set w/In-Line Chamber, 2 Spiros", Hanger - Product Usage: provides access for the administration of fluids from a container to a
• Z-1580-2021 · Mar 16, 2021 · Open, Classified
  REF CH3625 5" (13 cm) Appx 0.50 ml, Smallbore Trifuse Ext Set w/3 ChemoClave (Purple, Green Rings), Spiros w/Red Cap, 3 Clamps - Product Usage: provides access for the administrat
• Z-0704-2021 · Aug 31, 2020 · Open, Classified
  3mL Syringe w/Spinning Spiros, Red Cap, REF: CH2003; 5mL Syringe w/Spinning Spiros, Red Cap, REF: CH2005; 10mL Syringe w/Spinning Spiros, Red Cap, REF: CH2010; 20mL Syringe w/Spinn
• Z-0248-2021 · Jul 6, 2020 · Terminated
  6.5 IN (17 cm) APPX 0.78 ml, Ext Set w/Clave Clear, Clave 4-Way Stopcock, Spiros Red Cap;1 unit per pouch, 50 pouches per case. UDI:(01)10887709098878(17)241201(30)50(10)4493149.