ICU Medical CH2000S-10Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 00840619033910), received between Sep 23, 2020 and Jul 28, 2026 — classified as 6 malfunctions.

The most frequently reported specific device problem is “Fluid/Blood Leak” (4 reports).

5 other recalls cover devices cleared under the same FDA submission (K082806); 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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 28, 2026Disconnection

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50059740 ↗
• MalfunctionApr 21, 2026Separation Problem

  EVENT OCCURRED REGARDING A SPINNING SPIROS CLOSED MALE LUER, 10 UNITS WHERE IT WAS REPORTED THAT DURING A 5-FU PUMP INFUSION, THE SPIROS DEVICE CAME UNSCREWED FROM THE PUMP TUBING. IT DID NOT UNSCREW FROM THE BLUE CLAVE BUT FROM THE PUMP TUBING ITSELF. THEY REPORTED THAT ONCE SCREWED ON, IT SHOULD JUST SPIN AND NOT BE ABLE TO UNSCREW. THIS EVENT OCCURRED IN THE TOPSHAM OFFICE. THERE WAS PATIENT INVOLVEMENT BUT NO REPORTED HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24941717 ↗
• MalfunctionJul 8, 2021Fluid/Blood Leak; Fluid/Blood Leak

  THE CUSTOMER REPORTED THAT THE SPIROS LEAKED LEAKED WHILE PUSHING DOXORUBICIN. THE LEAK OCCURRED ON THE LUER CONNECTION BETWEEN SPIROS AND SYRINGE. THERE WAS PATIENT INVOLVEMENT BUT NO REPORTED HARM, THE ONLY PATIENT EXPOSURE WAS 2 DROPS ON PATIENT'S SWEATER. THE CHEMOTHERAPY SPILL WAS CLEANED UP PER PROTOCOL; HOWEVER, A SPILL KIT WAS NOT USED. THERE WAS NO ADVERSE EVENT OR DELAY IN THERAPY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12134350 ↗
• MalfunctionMay 25, 2021Fluid/Blood Leak; Fluid/Blood Leak

  THE EVENT INVOLVED A SPINNING SPIROS® CLOSED MALE LUER WHICH DISCONNECTED FROM THE LUER OF THE SYRINGE WHILE THE NURSE WAS BEGINNING TO ADMINISTER THE CHEMOTHERAPY (DOXORUBICIN) TO THE PATIENT. THE DRUG DID DRIP ONTO PATIENT AND PATIENT'S SHIRT; THE SHIRT WAS REMOVED, AND THE AREA WAS WASHED WITH SOAP AND WATER. THERE WAS PATIENT INVOLVEMENT, HOWEVER, THERE WAS NO HARM REPORTED AS A CONSEQUENCE OF THIS EVENT.

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

  MAUDE report 11881463 ↗
• MalfunctionOct 2, 2020Fluid/Blood Leak; Fluid/Blood Leak

  THE EVENT INVOLVED A SPINNING SPIROS® CLOSED MALE LUER, 10 UNITS THAT LEAKED BETWEEN THE SYRINGE AND THE SPIROS LUER LOCK WHEN THE NURSE WAS GETTING READY TO ADMINISTER A DOXORUBICIN INFUSION. IT WAS REPORTED THAT DILUTED CHEMO TOUCHED THE SKIN OF THE PATIENT¿S FOREARM WHEN THE SPIROS CAME DISCONNECTED FROM THE SYRINGE. THE AREA WAS WASHED IMMEDIATELY (SKIN REMAINED INTACT) AND THE CHEMO SPILL WAS CLEANED UP PER FACILITY PROTOCOL. THE TUBING WAS SET UP WITH INTRAVENOUS PUSH (IVP) ADMINISTERED AT LOWEST HUB OF THE UNKNOWN TUBING SET THAT WAS INFUSING NORMAL SALINE TO GRAVITY. THE SET UP AND DRUG WAS REPLACED AND ADMINISTERED SUCCESSFULLY WITHOUT FURTHER INCIDENT. THERE WERE NO HOLES, CUTS, TEARS OR ANY DEFECTS NOTED. THERE WAS PATIENT INVOLVEMENT AND NO ADVERSE EVENT REPORTED.

  Patient problems: Chemical Exposure; No Consequences Or Impact To Patient

  MAUDE report 10623275 ↗
• MalfunctionSep 23, 2020Disconnection; Fluid/Blood Leak; Disconnection; Fluid/Blood Leak

  THE EVENT INVOLVED A SPINNING SPIROS® CLOSED MALE LUER, 10 UNITS THAT THE CUSTOMER REPORTED A LEAK OF DOXORUBICIN. A BOLUS DOSE OF DOXORUBICIN WAS BEING ADMINISTERED AT THE LOWEST HUB OF THE NORMAL SALINE TUBING THAT WAS RUNNING TO GRAVITY. THE SPIROS CAME DISCONNECTED FROM THE SYRINGE, DILUTED CHEMOTHERAPY TOUCHED THE PATIENT'S FOREARM, AND THE AREA WAS WASHED IMMEDIATELY. THERE WAS PATIENT INVOLVEMENT, HOWEVER, NO DELAY IN DELIVERY DUE TO THE EVENT AND NO REPORT OF ADVERSE EVENT.

  Patient problems: Chemical Exposure; No Consequences Or Impact To Patient

  MAUDE report 10572526 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K082806. One submission often covers many models, so check the product and lot details in each record.

• Z-1723-2022 · Aug 1, 2022 · Open, Classified
  6.5 IN (17 cm) APPX 0.78 ml, EXT SET w/Clave CLEAR, Clave 4-WAY Stopcock, Spiros, RED CAP. Accessory for intravascular administration set.
• Z-1567-2021 · Mar 16, 2021 · Open, Classified
  REF 20124-01 30" (76 cm) Appx 3.2 ml, 20 Drop Admin Set w/Integrated Clave Drip Chamber, Spiros, Bag Hanger LOT 5142971 - Product Usage: provides access for the administration of
• Z-1568-2021 · Mar 16, 2021 · Open, Classified
  REF 20130-01 Spinning Spiros Closed Male Luer, Red Cap - Product Usage: provides access for the administration of fluids from a container to a patients vascular system through the
• Z-1569-2021 · Mar 16, 2021 · Open, Classified
  REF Spinning Spiros Closed Male Luer - Product Usage: provides access for the administration of fluids from a container to a patients vascular system through the administration se
• Z-0702-2021 · Aug 31, 2020 · Open, Classified
  30" (76 cm) Appx 3.2 ml, 20 Drop Admin Set w/Integrated Clave Drip Chamber, Spiros, Bag Hanger, REF: 20124-01; Spinning Spiros Closed Male Luer, Red Cap, REF: 20130-01; Spinning Sp